Current Retina Trials

Age-related Macular Degeneration (AMD)
Diabetes
Macular Telangiectasia Type 2 (MacTel)
Retinal Degenerations
Retinitis Pigmentosa
Retinoblastoma
Uvelitis and Ocular Immunology

 

Age-related Macular Degeneration (AMD)

Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk (Protocol W)

PI: Andrew Hendrick, MD
Coordinator: Linda Curtis
Status: Currently enrolling

General Summary:
The objectives of this study are to 1) determine the efficacy and safety of intravitreous aflibercept injections versus sham injections (observation) for prevention of PDR or CI-DME in eyes at high risk for development of these complications and 2) compare long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course of disease with those that are observed initially,

Clinical Summary:
If this study demonstrates that intravitreous aflibercept treatment is effective and safe for reducing the onset of PDR or CI-DME in eyes that are at high risk for these complications, a new strategy to prevent vision threatening complications of diabetes will be available for patients. The application of intravitreous aflibercept earlier in the course of disease (i.e., at the time when an eye has baseline severe NPDR) could help to reduce future potential treatment burden in patients, at the same time resulting in similar or better long-term visual outcomes, if PDR and DME are prevented

Inclusion Criteria:
1. Age >= 18 years
2. Diagnosis of diabetes mellitus (type 1 or type 2)
    •Any one of the following will be considered to be sufficient evidence that diabetes is present:
        a. Current regular use of insulin for the treatment of diabetes
        b. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
        c. Documented diabetes by American Diabetes Association and/or World Health Organization criteria
3. Able and willing to provide informed consent.

Meets all of the following ocular criteria in at least one eye:
1. Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity letter score ≥79 (approximate Snellen equivalent 20/25 or better)
2. Severe non-proliferative diabetic retinopathy (NPDR) (based on the 4:2:1 rule) evident on clinical examination and on digital imaging as judged by the investigator, confirmed by central Reading Center grading prior to randomization as ETDRS level 47B to 53E. Severe NPDR is defined as:
        a. All 4 mid peripheral quadrants show severe hemorrhages or microaneurysms (at least as great as Standard photograph 2A, approximately 20 dot and blot hemorrhages), or
        b. At least 2 fields of definite venous beading in the midperipheral quadrants or at least 1 field at least as severe as Standard photograph 6A, or
        c. At least 1 field of moderate intraretinal microvascular abnormalities (IRMA) in the midperipheral quadrants, at least as severe as Standard photograph 8A
3. No evidence of neovascularization on clinical exam including active neovascularization of the iris (small iris tufts are not an exclusion) or angle neovascularization (if the angle is assessed).
4. No evidence of neovascularization (NV) on fluorescein angiography within the 7-modified ETDRS fields, confirmed by the central Reading Center prior to randomization.
    •The widest method of imaging available at the site must be used to document whether there is NV present in the periphery; however, presence of NV outside of the 7-modified ETDRS fields on ultrawide field imaging will not be an exclusion provided treatment is not planned.
5. No center-involved diabetic macular edema (CI-DME) on clinical exam and optical coherence tomography (OCT) central subfield thickness must be below the following gender and OCT-machine specific thresholds:
        a. Zeiss Cirrus: 290 µm in women and 305 µm in men
        b. Heidelberg Spectralis: 305 µm in women and 320 µm in men
        c. Investigator and potential participant are comfortable withholding treatment for DME until there is at least a 10% increase in OCT central subfield thickness with confirmed visual acuity loss (10 letter loss at a single visit or 5 to 9 at two consecutive visits).
6. Prompt panretinal photocoagulation (PRP) or anti-vascular endothelial growth factor (anti-VEGF) treatment not required AND investigator and potential participant are willing to wait for development of high-risk characteristics (defined in protocol) to treat PDR.
7. Media clarity, pupillary dilation, and study participant cooperation sufficient to obtain adequate fundus photographs, fluorescein angiogram, and OCT.
    •Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality (including segmentation line placement)

Exclusion Criteria:
1. History of chronic renal failure requiring dialysis or kidney transplant.
2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
3. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months.
4. Participation in an investigational trial that involved treatment within 30 days of randomization with any drug that has not received regulatory approval for the indication being studied.
    •Note: study participants cannot participate in another investigational trial that involves treatment with an investigational drug while participating in the study.
5. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine prep).
6. Known allergy to fluorescein dye.
7. Blood pressure > 180/110 (systolic above 180 or diastolic above 110).     •If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
8. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
    •These drugs should not be used during the study.
9. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 2 years.
    •Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
10. Individual is expecting to move out of the area of the clinical center to an area not covered by another Diabetic Retinopathy Clinical Research Network certified clinical center during the next 2 years.

Individual has any of the following ocular characteristics in the eye(s) being evaluated:
1. Exam or photographic evidence of vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR.
2. History of prior vitreous hemorrhage or preretinal hemorrhage presumed to be from PDR.
3. History of prior PRP (defined as ≥100 burns outside of the posterior pole).
4. An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, vitreomacular traction, etc.).
5. History of DME or diabetic retinopathy treatment with laser or intraocular injections of medication within the prior 12 months and no more than 4 prior intraocular injections at any time in the past.
    •Enrollment will be limited to a maximum of 25% of the planned sample size with any history of treatment for DME and/or diabetic retinopathy. Once this number of eyes has been enrolled, any history of treatment for DME and/or diabetic retinopathy will be an exclusion criterion.
6. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
7. Any history of vitrectomy.
8. History of yttrium aluminum garnet capsulotomy performed within 2 months prior to randomization.
9. Aphakia.
10. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
11. Evidence of uncontrolled glaucoma.
    •Intraocular pressure must be <30, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible.

Contact: Linda Curtis, (404) 788-4261, ltcurti@emory.edu
Posted: 10-19-2016

 

A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (LADDER)

PI: Baker Hubbard, MD
Coordinator: Linda Curtis
Status: Currently enrolling

General Summary:
Study GX28228 is a Phase II, multicenter, dose-ranging, randomized, active treatment (monthly ITV injection)−controlled study to evaluate the efficacy, safety, and pharmacokinetics of ranibizumab delivered through the Implant using three ranibizumabformulation arms (10 mg/mL, 40 mg/mL, and 100 mg/mL) compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in patients with subfoveal AMD. The study will also evaluate the safety of the RPDS combination product.
Approximately 220 patients at up to 60 sites in the United States will be randomized in a 3:3:3:2 ratio to four treatment arms within an approximate 18-month period of time.

Inclusion Criteria:
•Age over 50 years
•Newly diagnosed with wet AMD within 6 months of screening visit
•Participant must have received at least 2 prior anti-VEGF injections. The most recent anti-VEGF injection must have been ranibizumab and must have occurred at least 7 days prior to the screening visit
•Participant may have received up to 6 ITV anti-Vascular Endothelial Growth factor (VEGF) injections prior to the screening visit
•Demonstrated response to prior SOC ITV anti-VEGF treatment
•Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/25-20/200 Snellen equivalent at the screening visit
•Willingness and ability to provide signed informed consent

Exclusion Criteria:
•Treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit in either eye
•Study eye treatment with ITV anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
•History of laser photocoagulation, Visudyne®, ITV corticosteroid injection, vitrectomy surgery, submacular surgery, device implantation, or other surgical intervention for AMD in the study eye
•Prior participation in a clinical trial involving anti-angiogenic drugs, other than ranibizumab, in either eye within 2 months of the randomization visit
•Subretinal hemorrhage in the study eye that involves the center of the fovea
•Subfoveal fibrosis, or atrophy in the study eye
•choroidal neovascularization (CNV) in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
•Uncontrolled ocular hypertension or glaucoma in the study eye
•Uncontrolled blood pressure
•Uncontrolled atrial fibrillation within 3 months of informed consent
•History of myocardial infarction or stroke within the last 3 months prior to informed consent
•History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant, that might affect interpretation of the results of the study or renders the participant at high risk of treatment complications
•Use of oral corticosteroids
•Current treatment for any active systemic infection
•Use of anticoagulants, anti-platelets (other than aspirin), or medications known to exert similar effects
•Active malignancy within 12 months of randomization
•History of allergy to fluorescein
•Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)

Contact: Linda Curtis, (404) 788-4261, ltcurti@emory.edu
Posted: 10-19-2016


NTMT503 A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared with Eylea® for the Treatment of Recurrent Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: starting enrollment

General Summary:
This research study is for an investigational new treatment; a treatment that has not yet been approved for marketing by regulatory authorities. This investigational treatment is called the NT-503-3 intraocular encapsulated cell technology (ECT) implant. This study will assess whether this experimental implant can be used to treat people with reoccurring wet AMD. The goal of this treatment is to ultimately avoid the need for frequent injections into the eye.

Clinical Summary:
The NT-503-3 ECT implant contains tiny capsules (smaller than a grain of rice) of living cells that continuously release a soluble VEGF receptor for an extended period. The ECT implant is surgically implanted into the eye with a minor procedure under local anesthesia.

The goal of this treatment is to ultimately avoid the need for frequent injections into the eye. The study will compare the safety and efficacy of the NT-503-3 ECT implanted in the eye to the Eylea® injection treatment every 8 weeks that is already available for wet AMD.

Inclusion Criteria:
•Male or female, age 50 years or older
•Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD, as determined by the reading center,in at least 1 eye, the study eye at the screening visit.
•Must have received at least 3 intravitreal anti-VEGF injections (Avastin®, Lucentis® or Eylea®) in the study eye with at least 1 injection of Avastin® or Lucentis® or Eylea® in the previous 4 months
•Vision 20/40 to 20/320 in the study eye and at least 20/200 in the non-study eye

Exclusion Criteria:
•Vision worse than 20/320
•never received any anti-VEGF injections
•Subretinal hemorrhage: More than 50% of total lesion size in the study eye, as determined by the central reading center.
•Scar and/or, fibrosis: More than 25% of the total lesion size in the study eye; scar, fibrosis or atrophy (includingRPE) involving the center of the fovea as determined by the reading center.
•Inadequately responsive to the most recent anti-VEGF therapy

Contact: Donna Leef, MMSc, COMT (404) 778-4134 dleef@emroy.edu
Posted: 05-18-2015

 

A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration

PI: Timothy W. Olsen, MD
Coordinator: Deborah Gibbs
Status: Recruiting

General Summary: Geographic atrophy (GA) is a form of dry age-related macular degeneration (AMD). GA causes progressive damage to the macula, the central region of the retina (inside the eye), which is involved in seeing the fine details associated with reading, driving, and recognizing faces.

In the advanced stage of the disease, GA results in severe central vision loss, which impairs performance of many activities of daily living. The cause of AMD is not well understood. However, recent scientific studies have found that people with specific inherited (genetic) characteristics have an increased risk of AMD.

Other scientific studies also suggest that an increased activation of a specific part of your immune system called the “alternative complement pathway” may be involved in the disease. Currently, there is no approved treatment for GA.

Lampalizumab, the study drug, is designed to slow down the activation of the alternative complement pathway and is given by injection into the eye. The trial visit schedule is once a month for a two-year commitment. Injections or shams will be given monthly. All study visits are covered by the sponsor.

Clinical Summary: In summary, the Phase II results from Study CFD4870g provided evidence that inhibition of the ACP with lampalizumab may slow the progression of GA and that lampalizumab administered as 10-mg intravitreal injections monthly over 18 months demonstrated an acceptable safety and tolerability profile in patients with GA secondary to AMD.

In addition, the exploratory genetic analyses suggest that there may be a biomarker-defined population (CFI profile biomarker-positive) that may have more rapid progression of disease and potentially derive greater efficacy benefit from lampalizumab than a group that is negative for the biomarker (CFI profile biomarker-negative).

On the basis of the findings from the Phase I and II studies, the Phase III study aims to further evaluate the efficacy and safety of lampalizumab as well as the potential for the CFI profile biomarker to identify patients who may have more rapid progression of disease and may derive greater benefit from lampalizumab treatment.

Inclusion Criteria:
1. ≥50 yrs. of age
2. VA equal or better than 20/100 SE
3. GA 2°to AMD ø CNV new or prior OU
4. Cataract surgery if ≥ 3 month prior
5. GA lesion size ≥1DA but ≤7DA
6. GA lesion must reside completely within the FAF imaging field OU
7. Presence of Hyper FAF of either banded or diffuse patterns adjacent to the area of GA SE
8. Valid CFI profile marker (test sent on scr date)
9. Relative clear ocular media, pupil dilation and fixation OU

Exclusion Criteria:
1. prior tx for AMD OU
2. prior tx for CNV, DME, RVO, PDR, CSR, RD, MH Stage 3 / 4 OU
3. PK (SE), Lasik, recurring eye infections or inflammation disease OU
4. RPE tear that involves the macula OU
5. eye problems (Cat, DR) that would need intervention to treat or prevent VA loss resulting from that disease or left untreated could ≥ 2 lines of VA loss during study
6. BP ≥180/110 sitting
7. Metabolic dysf, active systemic infection, malignancy, Ø Hx of Uveitis OU
8. predisposition or Hx of chronic immunosuppression/splenectomy
9. glaucoma-uncontrolled or filtering surgery OU

Contact: Deborah Gibbs, COMT, CCRC, CCRP 404-778-5815
Posted: 03-11-2014

 

A phase 3 randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of fovistatm (anti pdgf-b pegylated Aptamer) administered in combination with lucentis® compared to lucentis® monotherapy in subjects with subfoveal neovascular age-related macular degeneration

PI: Ghazala D. O’Keefe, MD
Coordinator:
Deborah Gibbs, COMT, CCRC, CCRP
Status: Closed to enrollment.

Summary: FovistaTM (also known under the code name of E10030) is an investigational drug being studied by Ophthotech Corp. and is for the treatment of age-related macular degeneration (AMD).  An investigational drug is one which has not been approved by the U.S. Food and Drug Administration (FDA).  FovistaTM (E10030) is given by injection into the vitreous, which is the clear, jelly-like substance that fills the middle of the eye.

Lucentis® (ranibizumab) is an approved drug for AMD, and is also given by injection into the vitreous.  Lucentis® is an “anti-VEGF” agent; that is, it blocks “vascular endothelial growth factor”, which plays a major role in the onset of wet AMD.

FovistaTM works differently than the “anti-VEGF” agent Lucentis®.  FovistaTM is an “anti-PDGF” agent; that is, it blocks a different growth factor— “platelet-derived growth factor”—that also plays a role in wet AMD. In two previous studies, FovistaTM combined with Lucentis® was well tolerated.  Although these studies revealed that the combination of Lucentis® and FovistaTM may have the potential to stop or reverse the growth of abnormal blood vessels in the eye and can possibly improve vision, you may or may not benefit from receiving FovistaTM in addition to Lucentis®, by participating in this study.

The purpose of this study is to further evaluate the effects of Fovista™ in patients with wet AMD, and how Fovista™ is absorbed into the body, when administered in combination with Lucentis®.

This study will involve approximately 622 men and women ages 50 years or older world-wide. We expect 15-20 here at Emory.  Your participation in this study will last approximately 24 months.

Inclusion Criteria

• BCC  Study Eye  20/63-20/200
• Wet AMD
• Total area <5 Disc areas  50% active CNV (active leakage and sub/intraretinal fluid on OCT
• OCT results of sub/intraretinal or sub-RPE fluids/o SR thick/reflectivity consistent with active CNV
• IOP 21 or less
• >50 yo
• Ability to comply with 24-26 visits, etc.

Exclusion Criteria

FPrior intravitreal tx in study eye
25% if the total lesion size consisting of subretinal  H+
>50% of total lesion size SRH
Presence of significant Serous PED (such as large PED that constitute greater than 50% if the total lesion)
Pigment epithelial tears or rips
Intraocular inflammation
Sig cataracts requiring sx in 12 months
Presence of Pathologic myopia, histo, angioid streaks, choroidal rupture, multifocal choroiditis
Hx of RRD, PPV, Trab, Glaucoma drainage device, PK
Radiation in the region of the study eye.
DM or A1c of >6.5
Metabolic dysfunction
Labs results showing underline problems
HX or evidence of Severe Cardiac disease
Unstable angina
Acute coronary syndrome
MI
Coronary Revascularization w/in 6 mo
Ventricular tachyarrhythmia’s  ongoing tx
Stroke w/in 12 months of trial
Major surgery w/in 1 month
Any tx w/investigation agent w/in 60 days for any condition
Allergy to FA dye, Lucentis, Fovista

Contact: Deborah Gibbs, COMT; 404-778-5815
Sponsor: Ophthotech
Posted: 04-23-2014

 

A Prospective, Multicenter Post-Approval Study of VisionCare's Implantable Miniature Telescope in Patients with Bilateral Severe to Profound Central Vision Impairment Associated with End-Stage Age-Related Macular Degeneration

PI: Joung Kim, MD
Coordinator: Jayne Brown
Status: Enrolling

General Summary: The purpose of the IMT PAS 01 is to evaluate the safety of the intraocular telescope for the treatment of bilateral end-stage age-related macular degeneration following U.S. market approval

Clinical Summary: Patients will be closely followed for 5 years post implantation. Clinical parameters for both eyes: slit lamp & fundus exams, BCVA, IOP and corneal endothelial cell density measurement.

Inclusion Criteria:
- Retinal findings of geographic atrophy or disciform scar
- Evidence of significant cataract
- Achieve 5 letter improvement with an external telescope
- Agree to participate in post op visual training
- Minimum age of 65 years

Exclusion Criteria:
- Stargardt's macular dystrophy
- Corneal guttata
- Must meet endothelial cell density requirements per protocol

Contact: Jayne Brown, Clinical Research Coordinator, 404-778-4430
Date Posted: 02-02-2012;
Updated: 11-03-2014; 04-27-2016

 

Diabetes

DRCR: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

PI: Jiong Yan, MD
Coordinator: Judy Brower, COMT
Status: Enrollment Closed

General Summary: Standard treatment for Proliferative Diabetic Retinopathy (PDR) is laser. This study is to determine whether injections of a drug into the eye can treat PDR as well as laser treatment but with fewer side effects. Half of those enrolled will receive laser immediately, the other half will receive monthly injections as long as needed or until it is determined that laser is needed. Eyes that receive injections will have visits monthly as long as injections are needed. Eyes that received prompt laser will be seen every 16 weeks, unless needed to be seen more often. Follow-up will be 5 years - Years 4 and 5 are yearly visits only.

Inclusion Criteria:
- At least 18 years of age
- Type I or II diabetes mellitus
- Proliferative Diabetic Retinopathy

Exclusion Criteria:
– History of previous PRP laser
– Any condition affecting visual acutiy other than PDR
– History of eye injection (anti-VEGF) in the past 2 months.
– History of corticosteroid treatment in the past 4 months
– Major ocular surgery in past 4 months or expected in next 6 months
– History of YAG laser in past 2 months

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 07-24-2012; 01-18-2013

 

DRCR: Genes in Diabetic Retinopathy Project
PI: Jiong Yan, MD
Coordinator: Linda Curtis
Status: currently enrolling

General Summary: The purpose of this study is to collect blood and DNA from diabetics for scientists to study. These samples will be stored at a Research Bank in Seattle, Washington. Information about the samples will be stored in Tampa, Florida.

Scientists may request some samples for their research on diabetes, complications from diabetes, such as diabetic retinopathy or other diseases. The DRCRnetwork will need to approve the request before the samples will be given to the scientists. One or two tubes of blood will be drawn. The information collected may be updated with information about eye exams, diabetes, other medical conditions, and treatments. There will be at least 2000 people in this study.

Inclusion Criteria: Currently or previously enrolled in one of the applicable DRCR.net studies

Exclusion Criteria

Contact: Linda Curtis, 404-778-4261
Date Posted: 07-24-2012; 07082013

 

Macular Telangiectasia Type 2 (MacTel)

MacTel - A Phase 2 Multicenter Open Label Safety and Tolerability Clinical Trial of Ciliary Neurotropic Factor (CNTF) in Patients with Macular Telangiectasia Type 2 (MacTel) - Protocol NTMT-02
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: recruitment closed, follow-up phase

General Summary:
MacTel is a disorder of the blood vessels which supply the macula, the central part of the retina that lines the back of the eye and picks up the light like the film in a camera. The “fovea,” in the center of the macula, has no blood vessels at all because they would interfere with central vision. MacTel refers to a curious, very poorly understood condition of the blood vessels around the fovea (juxtafoveal) which become dilated and incompetent, like varicose veins but on a much smaller scale.

While MacTel does not usually cause total blindness, it commonly causes loss of the central vision, which is required for reading and driving vision, over a period of 10-20 years. There is no current approved treatment for MacTel. This study will evaluate whether an experimental implant containing Ciliary Neurotrophic Factor (CNTF) can be used to treat people with MacTel. CNTF is a small molecule that may help keep some nerve cells in the eye healthy. The implant, called NT-501, is a small capsule of cells that is placed inside the eye to allow the release of CNTF directly to the retina, the light sensitive part of the eye.

Clinical Summary:
This study will have two equal groups:
(A) NT-501 implant: the surgical implantation of the NT-501 implant
(B) Sham procedure: the placement of a dissolvable suture on the eye. A Sham procedure does not involve any treatment. It is like a control or placebo group

Inclusion Criteria:
Some of the inclusion criteria include:
• Age 21 to 79
• Must have at least one study eye with a diagnosis of MacTel Type 2 with evidence of fluorescein leakage typical of MacTel or at least one of the other features including retinal opacification, crystalline deposits, right angle vessels, inner/outer lamellar cavities or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal neovascularization
• Vision 20/50 or better
• After study testing and measurements at the screening visit, study eligibility requirements are met and confirmed by an independent reading center

Exclusion Criteria:
• Received intravitreal therapy for non-neovascular MacTel within the last 3 months (steroids) and within the last month (anti-VEGF)
• Is pregnant or breastfeeding
• Has a history of malignancy that would compromise the 24-month study survival
• Is on immunosuppressive therapy
• Is considered immunodeficient or has a known history of HIV;
• A history of ocular Herpes virus

Contact: Donna Leef, MMSc, COMT, (404) 778-4134, dleef@emory.edu
Posted: 05/13/2015

 

Retinital Degenerations

A Compassionate Use of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor for Participants with Retinal Degenerative Diseases
PI: Jiong Yan, M.D.
Coordinator: Donna Leef, MMSc, COMT
Status: follow up

General Summary:
This study is to collect extended data on patients who were previously implanted with a capsule which releases a substance called “CNTF” into the fluid of ther eye. CNTF is a naturally occurring substance in the body that acts to protect nerve cells. The CNTF implants were developed by Neurotech Pharmaceuticals USA, the sponsor of this trial. All of the enrolled 9 participants have had the capsule implanted for more than 24 months.

Clinical Summary:
To further evaluate participant safety and to continue collecting information on the effectiveness of the implant, we are asking those patients who were originally implanted to continue participating in this study for one additional “extension” study visit. The additional study visit will take place between Month 26 and 50 after the date of the implant.

Inclusion Criteria: Previous participant in the Compassionate Use of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor for Participants with Retinal Degenerative Diseases between 2011 and 2012.

Exclusion Criteria:
Not a participant in the Compassionate Use of Encapsulated Human NTC-201 Cell Implants Releasing Ciliary Neurotrophic Factor for Participants with Retinal Degenerative Diseases between 2011 and 2012

Contact: Donna Leef, MMSc, COMT (404) 778-4134, dleef@emory.edu
Posted: 05/14/2015

 

Retinitis Pigmentosa

Argus II Retinal Prosthesis System Post Approval Study (Protocol PM-02-01)
PI: Jiong Yan, MD
Coordinator: Jayne Brown
Status: Active

General Summary: The purpose of this study is to collect additional information from Argus II users in order to monitor the system's safety and collect additional data about how much it improves people's visual function and activities of daily living.

Clinical Summary: This study is a 5 year post-market approval study, to collect additional information regarding safety and performance of the ARGUS II. The ARGUS II is approved as a Humanitarian Use Device.

Inclusion Criteria:

- at least 25 years old
- severe to profound retinitis pigmentosa diagnosis
- previous history of useful form vision
- bare or no light perception in both eyes

Exclusion Criteria:
- ocular structures or conditions preventing successful working of or implantation of the device
- inability to tolerate general anesthesia, or antibiotic and steroid regimen
- pregnancy or plans to become pregnant during course of study

Contact: Jayne Brown, 404-778-4430 office phone

Posted: 01-02-14

 

Uvelitis and Ocular Immunology

CLS1001-301 (PEACHTREE): A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects with Macular Edema associated with Non-Infectious Uveitis

PI: Steven Yeh, MD
Coordinator:
Jayne Brown
Status:
Enrolling

General Summary:
This is a phase 3, randomized, sham controlled, multi-centered study to evaluate the safety and efficacy of 4 mg suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.

Clinical Summary:
The study design includes a maximum of 8 clinic visits over a maximum of 27 weeks. Qualified subjects will be randomized to receive 2 unilateral suprachoroidal injections of CLS-TA to the study eye or 2 unilateral sham injection procedures approximately 12 weeks apart. Local medications for fellow eye are allowed. Rescue criteria is determined by protocol guidelines with treatment determination at Investigator's discretion.

Inclusion Criteria:
1. Non-infectious uveitis of any etiology and from among those with anterior, intermediate, posterior and pan uveitis.
2. Macular edema greater than 300 microns determined by OCT.
3. BCVA between 20/70 and 20/800 Snellan equivalent.
4. 18 yrs or older.

Exclusion Criteria:
1. Significant media opacity.
2. IOP greater than 22 mmHg (can be on 2 IOP lowering medications) or uncontrolled glaucoma.
3. History of vitreoretinal surgery within 3 months prior to Visit 2.
4. High myopia (greater than 26mm axial length).
5. Photocoagulation or cryotherapy 6 months prior to Visit 2.
6. Intravitreal injection of anti-VEGF treatment within 30 days.
7. Topical ocular corticosteroid within 10 days, intraocular and periocular corticosteroid injection within 2 months, OZURDEX implant within 6 months, RETISERT or ILUVIEN insert within 3 years of Visit 2.
8. Systemic steroids greater than 20 mg per day within 2 weeks of Visit 2. Subjects on stable dose of less than 20 mg per day with no anticipated dose increase during study can be enrolled.

Contact: Jayne Brown, (404) 778-4430
Date Posted: 04-18-2016

PeriOcular and INTravitreal corticosteroids for uveitic macular edema (POINT)
Trial PI: Steven Yeh, MD, Associate Professor of Ophthalmology Coordinator: Alcides Fernandes Filho, MD
Status: Recruiting

General Summary: Macular edema is the most common complication and leading cause of visual loss in patients with uveitis. Approximately 40% of patients with intermediate uveitis, posterior uveitis, or panuveitis develop macular edema. Ocular injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of administration (e.g. periocular, intravitreal). The question of how to approach local treatment of uveitic macular edema is a key question for ophthalmologists treating these patients.

The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone, intravitreal triamcinolone, and the intravitreal dexamethasone implant.

The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. Follow-up through 24 weeks will allow evaluation of the duration of response and the need for additional injections. Secondary outcomes include resolution of macular edema, IOP elevation, visual acuity, complications of treatment, and cost-effectiveness.

Clinical Summary: The POINT Trial was designed to evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant.

After signing informed consent and undergoing eligibility evaluation, eligible patients will be randomized to one of the three study treatments to be administered at the first study visit. Randomization is by participant, if both eyes meet eligibility requirements then both eyes receive assigned treatment. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks.

After assessment of the primary outcome at 8 weeks, second injections and best medical judgment will be used if macular edema has not improved as follows:

Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at P01 visit.

Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if

- Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) or
- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield or
- ME is worse after initial improvement And the following repeat injection criteria are met:

- IOP of ≤21 or mm Hg and treatment with ≤2 IOP-lowering agents;

- Best corrected visual acuity of 20/40 or worse;

Eyes demonstrating no improvement or worsening of ME as measured by the central submacular thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week 20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.

Inclusion Criteria:
1. 18 years of age or older;

Eye level inclusion criteria - at least one eye must meet all of the following conditions:
2. Non-infectious anterior, intermediate, posterior or panuveitis; either active or inactive uveitis is acceptable;
3. Macular edema (ME) defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used, regardless of the presence of cysts, as assessed by study ophthalmologist;
4. Best corrected visual acuity (BCVA) worse than 20/32 and 5/200 or better;
5. Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 2 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable);
6. Baseline fluorescein angiogram that is gradable for degree of leakage in the central subfield
7. Pupillary dilation sufficient to allow OCT testing.

Exclusion Criteria:
1. History of infectious endophthalmitis or infectious uveitis in either eye;
2. History of scleritis or keratitis of any type in either eye;
3. For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
4. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
5. Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day that has not been stable for at least 4 weeks;
6. Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
7. Known allergy or hypersensitivity to any component of the study drugs;

Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions:
8. History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
9. Media opacity causing inability to assess fundus or perform OCT;
10. Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface) 81;
11. Presence of silicone oil;
12. Periocular or intravitreal corticosteroid injection in past 8 weeks;
13. Injection of dexamethasone intravitreal implant in past 12 weeks;
14. Placement of fluocinolone acetonide implant (Retisert) in past 3 years;
15. Topical NSAID use if dose has not been stable for at least 4 weeks.

Contact: Alcides Fernandes Filho, (404) 778-2421, afilho@emory.edu
Date Posted: 11-3-2015

 

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis: The EYEGUARD™, A Study

PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary: The purpose of this study is to find out more about how gevokizumab works, and if it has an effect on eye condition by limiting the action of IL-1β, one of the proteins in the body that causes inflammation. Patients will be followed through Visit Day 448 and will have the option to roll into an open label study if necessary.

Clinical Summary: The primary objective of this study is to demonstrate the superiority of gevokizumab (at least one of the two doses) compared to placebo in the treatment of subjects with active non-infectious intermediate, posterior, or pan- uveitis. In addition, the safety of gevokizumab will be assessed.

Inclusion Criteria:
-active non-infectious intermediate, posterior or pan uveitis indicated by 2+ vitreous haze in one eye
-on current stable treatment regimen

Exclusion Criteria:
-history or symptoms of demyelinating disease
-seropositivity for HIV, Hepatitis B or C
-advanced glaucoma, or on >3 IOP lowering medications

Contact: Jayne Brown, 404-778-4430
Date Posted: 05-08-2014
Last Updated: 04-27-2016

 

A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects with Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled with Systemic Treatment: The EYEGUARD™-C study

PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed to enrollment.

General Summary: The purpose of this study is to find out more about how gevokizumab works, and if it has an effect on eye condition by limiting the action of IL-1β, one of the proteins in the body that causes inflammation. Patients will be followed through Visit Day 448 and will have the option to roll into an open label study if necessary.

Clinical Summary: The primary objective of this study is to demonstrate the superiority of gevokizumab (at least one of the two doses) compared to placebo in reducing the risk of recurrent uveitic disease in subjects with non-infectious intermediate, posterior, or pan- uveitis currently controlled with systemic treatment. In addition, the safety of gevokizumab will be assessed.

Inclusion Criteria:
-history of active uveitis disease in either eye within 12 months
-controlled uveitis with <0.5 vitreous haze in both eyes
-on stable dose of corticosteroids > 10mg/day

Exclusion Criteria:
-advanced glaucoma or on >3 IOP lowering medications
-seropositivity for HIV or Hepatitis B or C
-history or symptoms of demyelinating disease

Contact: Jayne Brown, 404-778-4430
Date Posted: 05-08-2014
Last Updated: 04-27-2016

 

A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients with Non-Infectious Anterior Segment Uveitis

PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Open to enrollment

General Summary: The purpose of this study is to see how well a new drug and associated drug delivery system treat patients with non-infectious anterior uveitis compared to Prednisolone Acetate (positive-control eye drops), the standard of care.The study drug, Dexamethasone Phosphate, and associated drug delivery system, ocular iontophoresis are investigational, which means they have not yet been approved by the United States Food and Drug Administration (FDA).

Clinical Summary: This is a prospective, multi-center, randomized, double-masked, Phase 3 clinical trial designed to evaluate the efficacy and safety of ocular iontophoretic delivery of dexamethasone phosphate ophthalmic sloution to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Inclusion Criteria: Adults diagnosed with non-infectious anterior segment uveitis defined as an anterior chamber cell count greater than or equal to 11 cells.

Exclusion Criteria:
- Have intermediate or posterior uveitis.
- Have used topical corticosteriod in the study eye less that 48 hours prior to Baseline Visit.
- Have used oral corticosteroid within 14 days of Baseline Visit.
- Steroid responder in either eye.

Contact: Jayne Brown, Clinical Research Coordinator, 404-778-4430
Sponsor: Eyegate Pharmaceuticals
Date Posted: 07-25-2012
Last Updated: 04-27-2016

 

Adalimumab-327
PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary: All patients will receive open label adalimumab regardless of their previous treatment assignment in the randomized, double masked studies. Maximum duration of this study is 78 weeks.

Clinical Summary: Patients who discontinue from M10-880 and M10-877 will receive adalimumab 40 mg eow SC. Concomitant oral or topical corticosteroids and any one of the allowed immunosuppressive therapies permitted in the previous trial will be allowed as necessary to control ocular inflammation in patients with active disease. Patients are followed very closely with clinical examinations and laboratory testing.

Inclusion Criteria:
-patients previously enrolled in either M10-880 or M10-877 who have discontinued or completed these protocols.

Exclusion Criteria:
-IOP greater than 25mmHg and on 2 glaucoma medications
-pregnancy
-isolated anterior uveitis

Contact: Steven Yeh, MD at 404-778-5070 or Jayne Brown 404-778-4430
Sponsor: Abbott Laboratories
Date Posted: 05-25-2011

 

Adalimumab-877
PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab as Maintenance Therapy in Subjects Requiring High Dose Corticosteroids for Active Non-infectious Intermediate, Posterior or Panuveitis.

Clinical Summary: The objective of this study is to evaluate efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week subcutaneously staring at Week 1 compared to placebo as maintenance therapy in patients requiring high dose corticosteroids for active uveitis.

Inclusion Criteria:
- patients with active disease despite 2 weeks maintenance therapy of greater than 10 mg prednisone
- prior adequate response to oral corticosteroids
- negative TB screening

Exclusion Criteria:
- isolated anterior uveitis
- IOP greater than 25 mmHg and on 2 glaucoma medications
- previous exposure to anti-TNF therapy

Contact: Steven Yeh, MD at 404-7785070 or Jayne Brown at 404-778-4430
Sponsor: Abbott Laboratories
Date Posted: 04-19-2011

 

Adalimumab-880

PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed to enrollment

General Summary: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Inactive Non-infectious Intermediate-, Posterior-, or Pan-uveitis.

Clinical Summary: This is a phase 3, randomized, double masked, placebo-controlled, multi-centered study to investigate the efficacy and safety of adalimumab in uveitis subjects who are unable to taper cortiosteroids without experiencing a flare.

Inclusion Criteria:
- noninfectious, intermediate, posterior or panuveitis
- AC cell grade and haze less than 0.5+
- history of having failed corticosteroid taper within 18 months

ExclusionCriteria:
- corneal or lens opacity that precludes fundus visualization
- isolated anterior uveitis
- less than 20/200 in one eye

Contact: Steven Yeh, MD at 404-778-5070, or Jayne Brown at 404-778-4430
Date Posted: 11-29-2010
Last Updated: 01-13-2015

 

A 24 week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious, intermediate, posterior, or panuveitis (ENDURE and 38 week ENDURE Extension study).

PI:  Steven Yeh, MD
Coordinator: Jayne M. Brown
Status: Closed to enrollment

General Summary: This study will find out if AIN457 along with standard treatment could suppress and prevent and active uveitis recurrence as compared to standard treatment alone.

Clinical Summary: Patients will be randomized to AIN457 versus placebo and receive subcutaneous injections during a 24 week treatment period. Patients are followed with clinic examinations every other week for 24 weeks.

Inclusion Criteria:
- less than grade 1, AC cell and vitreous haze
- no increase in immmunosuppressive medications within 6 wks
- patients willing to be weaned from current systemic therapy
- at least 18 years old

Exclusion Criteria:
- patients requiring greater that 1 mg/kg daily of cortocosteroids to maintain quiescence
- infectious uveitis
- active uveitis with AC cell or vitreous haze greater than grade 1
- pregnancy
- intravitreal anti-VEGF agents within 3 months

Contact: Jayne M. Brown, 404-778-4430

 

AIN457 An open-label, proof-of-concept study with a double-masked, dose ranging component to access the effects of AIN457 in patients with non-infectious uveitis

PI: Steven Yeh, MD
Coordinator:
Jayne M. Brown
Status: Closed to enrollment

Summary: This trial examines the study drug AIN457, given by infusion, to see if it is safe and has beneficial effects for patients with non-infectious uveitis.

Inclusion criteria:  
Patients 18 -75 years with non-infectious uveitis requiring systemic immunosupression. Screening vitreous haze and anterior chamber cell scores must be +1 or worse.

Exclusion criteria:
Systemic disease that would contraindicate long-term immunosupression, especially infectious diseases that can spontaneously re-emerge such as tuberculosis; white blood cell or platelet count below normal; abnormal EKG; ocular surgery within 6 months; laser in study eye within 3 months.

Contact:  Jayne M. Brown, 404-778-4430
Sponsor:  Novartis Pharmaceuticals
Last Updated: 07-24-2012

 

Multicenter Uveitis Steroid Treatment (MUST) Trial

PI:  Steven Yeh, MD
Coordinator: Alcides Fernandes, MD
Status: Closed to enrollment

Summary: This research was designed to determine if a new FDA approved treatment is safer and more effective than the standard treatment for certain types of uveitis. The two treatment arms of this study are a corticosteroid implant (the new FDA approved treatment, Retisert® implant) and oral corticosteroids (the standard FDA approved treatment). Both treatments are known to be effective for treating uveitis. Neither treatment is experimental.

Inclusion Criteria
- Patients with active intermediate, posterior, or pan-uveitis
- 13 years or older
- Best corrected VA of hand motion or better
- Baseline Intraocular pressure of 24mm Hg or less

Exclusion Criteria
- Patients with Diabetes Mellitus
- Allergy to steroids
- Uncontrolled glaucoma or advanced glaucomatous optic nerve damage
- Immunocompromised patients
- Pregnant or currently breast-feeding patients

Contact: Alcides Fernandes, MD, 404-778-2421
Sponsor: NEI, NIH

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