Closed Retina Trials

 

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:
Closed

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
Updated: 08-31-2017; 05-15-2018


The AREDS2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)

PI: G. Baker Hubbard, MD
Coordinator: Linda Curtis
Status: Closed.

General Summary: The A2A SDOCT is a new method of gathering images of the eye to detect and measure changes in very small eye structures. In this study, the SDOCT imaging system is used to gather information from the reflection of light off the many structures in and beneath the retina. The images are stacked up to create a 3-dimensional picture of the back of the eye.

Inclusion Criteria:
- AREDS2 participants
- Normal control subject without AMD

Contact: Linda Curtis 404-778-4261
Updated:  05-20-2016


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.

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, 01-22-2018


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™, A Study

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

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; 01-22-2018


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.

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
Last Updated: 01-24-2018


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.

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; 01-23-2018


Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device
PI: G. Baker Hubbard, III, MD
Coordinator: Linda Curtis
Status: Closed.

General Summary: This study is to determine whether the use of this device which monitors vision helps to detect progression to wet AMD earlier than standard of care (Amsler grid). Half of the participants will receive the ForeseeHome Device, the other half will continue monitoring with Amsler grid. If an eye develops wet AMD during the study, we would also like to determine whether there is a difference in visual acuity between the 2 groups after 3 monthly injections of Lucentis or Avastin at month 3 and at 1 year.

Inclusion Criteria:
- Large drusen in both eyes or large drusen in one eye and advanced AMD in the other eye
- English speaking
- Demonstrate ability to understand use of the device after a tutorial
- Willing to return for eye exam if device detects changes

Exclusion Criteria:
- Retina disease other than AMD in the study eye
- Known reaction to fluorescein
- Eye exam by eye care professional more often than every 4 months

Contact: Linda Curtis, 404-778-4261
Last Updated: 07-31-2012; 05-20-2016


An Evaluation of Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy

PI: Blain Cribbs, MD
Coordinator: Judy Brower
Status: Closed.

General Summary: The purpose of this study is to determine whether Intravitreal injections of Ranibizumab decrease the proportion of eyes in which vitrectomy is performed by comparing with Intravitreal saline injections in eyes with vitreaous hemorrhage from proliferative diabetic retinopathy.

Clinical Summary: This study consists of 5 visits and 1 telephone call during 1 year. An Intravitreal injection (Ranibizumab or saline) will be given at baseline and possibly the next 2 study visits, which are 4 weeks and 8 weeks. A follow up visit is conducted at 12 and 52 weeks. ETDRS visual acuity, OCT, and eye exams are performed at each visit. Ultrasound may be needed. Blood is drawn for HbA1c unless results are available from previous 3 months.

Inclusion Criteria:
-
At least 18 years of age
- Type 1 or 2 Diabetes Mellitus
- Study eye must have vitreous hemorrhage from proliferative diabetic retinopathy causing vision impairment (precluding completion of PRP or precluding assessment of completeness of prior PRP)
- Willingness to wait at least 8 weeks to see if hemorrhage clears without having vitrectomy
- Visual aucity light perception or better

Exclusion Criteria:
- Prompt vitrectomy needed
- History of Intravitreal anti-VEGF for vitreous hemorrhage any time in the past or for any reason in the past 2 months
- History of vitrectomy
- History of major ocular surgery in prior 4 months
- Aphakia
- Uncontrolled glaucoma
- Yag capsulotomy in past 2 months
- Cardiac event requiring hospitalization, stroke, treatment for congestive heart failure in past 4 months

Contact: Judy Brower, MMSc, COMT 404-778-4725
Last Updated: 02-29-2012; 07-08-2013


Comparison of AMD Treatments Trials (CATT)

PI: G. Baker Hubbard, MD
Coordinator: Lindy DuBois, MEd, MMSc, CO, COMT
Status: Completed.
Summary: Comparison of Lucentis vs Avastin and fixed vs variable dosing in the treatment of a new onset of wet AMD.

Inclusion Criteria:
- Age 50 and older.
- New untreated active wet AMD
- Vision worse than 20/25 and better than 20/300

Exclusion Criteria:
- Previous treatment or surgery for AMD in the study eye
- Other ocular disorders in the study eye
- Myopia greater than -8D
- Intraocular surgery within the last 2 months
- Pregnancy or lactation
- Significant uncontrolled systemic disease, infection, or inflammation

Contact: Lindy DuBois, 404-778-4443,
Sponsor: NIH/NEI
Last Updated:
07-31-2012


An Observational Study in Individuals with Diabetic Retinopathy without Center-Involved SME Undergoing Cataract Surgery (Protocol Q)

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

General Summary: Observational study only. The purpose is to determine how often center involved macular edema occurs 16 weeks after cataract surgery in eyes with diabetic retinopathy without center involved DME. This study is for diabetic patients about to have cataract surgery and consists of 3 study visits; one within 28 days before the surgery; one about 4 weeks after surgery; and one about 16 weeks after surgery.

Clinical Summary: Each study visit will consist of ETDRS refraction and visual acuity, OCT, and fundus exam.

Inclusion Criteria:
- At least 18 years of age.
- Presence of cataract.
- Diagnosis of Deabetes Mellitus.
- Presence of microaneurysms or at least mild NPDR on clinical exam
- Visual Acuity Light Perception or better.
- OCT central subfield thickness </= 250 microns.

Exclusion Criteria:
Any ocular condition other than cataract that might affect visual acuity.

Contact: Judy Brower, COMT, 404-778-4725
Last Updated: 02-29-2012; 07-08-2013


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

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
Last Updated: 01-23-2018


Implantable Miniature Telescope - Long Term Monitoring Extension (IMT002-LTME)
P I: Chris Bergstrom, MD
Coordinator: Jayne Brown
Status: Closed

General Summary: Participants will receive thorough ophthalmic examinations and specular microscopy in long term follow up.

Clinical Summary : Retina and cornea evaluations will be obtained for patients who have had surgery for the Implanable Miniature Telescope.

Inclusion Criteria: Patients who participated in the original miniature telescope implantation trial will return for long term follow up.

Exclusion Criteria:

Contact: Jayne Brown 404-778-4430 or Chris Bergstrom, MD, 404-778-4745
Date Posted: 05-06-2011; date posted as closed: 01-30-2012


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

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
Last Updated: 01-23-2018


Adalimumab-880
PI: Steven Yeh, MD
Coordinator: Jayne Brown
Status: Closed.

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; 01-23-2018


Pilot Study in Individuals with Center-Involved Diabetic Macular Edema Undergoing Cataract Surgery (Protocol P)

PI: Jiong Yan, MD
Coordinator: Judy Brower, COMT
Status: Discontinued

General Summary: Observational study only. This study is for diabetic patients with macular edema about to have cataract surgery and consists of 2 study visits; one within 2 weeks before the surgery and the other about 16 weeks after the surgery.

Clinical Summary: Each study visit will consist of ETDRS refraction and visual acuity, OCT, and dilated eye exam. The doctor may decide photographs with fluorescein dye are needed.

The cataract surgery is not part of the study.

Inclusion Criteria:
- At least 18 years of age.
- Diagnosis of Diabetes Mellitus
- Visual Acuity Light Perception or better
- OCT central subfield thickness >/=250 microns

Exclusion Criteria: Any ocular condition other than cataract and DME that might affect visual acuity

Contact: Judy Brower, 404-778-4725 judy.brower@emoryhealthcare.org

Date Posted:  2/23/2010


Multicenter Uveitis Steroid Treatment (MUST) Trial
PI:  Steven Yeh, MD
Coordinator: Alcides Fernandes, MD
Status: Closed.

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
Updated: 01-19-2018


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.

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
Last Update: 01-23-2018


Longitudinal Study of Ocular Complications of AIDS
PI: Steven Yeh, MD
Coordinator: Deborah Gibbs, COMT, CCRC
Status: Closed enrollment

Summary: The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is a multicenter, prospective, observational study of patients with AIDS. Patients with a diagnosis of AIDS according to the 1993 CDC criteria, with or without ocular opportunistic infections, will be enrolled. The objectives of the study are:

- To monitor secular trends in the incidence of CMV retinitis and other ocular complications of AIDS.
- To determine the effect of HAART-induced changes in immune status on the risk of CMV retinitis and other ocular complications of AIDS.
- To determine the characteristics (clinical, virologic, hematologic, and biochemical) of populations at high risk for CMV retinitis and other ocular complications of AIDS.

Approximately 2,800 patients will be enrolled in the study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. All patients will be on a 6-month followup schedule; and have telephone contacts at the 3-month time point between visits. Data will be collected from eye examinations, fundus photographs, visual function testing, medical history, quality of life assessment, laboratory studies, and collection of plasma and blood cells for banking. Banked specimens will be analyzed for HIV RNA levels and CMV DNA levels. Outcomes of primary interest are incidence of CMV retinitis, incidence of other ocular complications, and mortality. Other outcomes of interest include incidence of extra-ocular CMV disease, sequelae of AIDS-related eye disease (e.g., retinal detachment), visual function, quality of life, and incidence of complications of therapies for ocular complications.

Inclusion Criteria:
- CD4 less than 200 at any time on or after January 1, 2001. CD4 can be much higher now with or without eye problems.

And/or

- Within 45 days of being diagnosised with one of the following:
- - CMV
- - Herpetic retinitis
- - Toxoplasmic retinitis
- - Cryptococcal Choroidopathy
- - Pneumocystic Choroidopathy

Exclusion Criteria: None

Contact: Deborah Gibbs, COMT, CCRC, 404-778-5815 or pager 404-896-2711
Sponsor:
National Institutes of Health Johns Hopkins University


A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients with non-Infectious Anterior Segment Uveitis
PI: Sunil Srivastava, MD
Coordinator: Jayne M. Brown
Status: enrollment closed

Summary:  This randomized trial will evaluate the efficacy of four doses of Dexamethasone using a novel delivery system for Anterior Uveitis.

Inclusion Criteria:
1. Non-infectious anterior uveitis defined as anterior chamber cell less than 1.5 (11 cells or less).
2. No elective ocular surgery during the study.

Exclusion Criteria:
1. Previous anterior uveitis episode less than 4 weeks prior to baseline.
2. Treatment for any type of uveitis in either eye within 2 weeks of presentation for enrollment.

Contact: Jayne M. Brown, 404-778-4430
Sponsor: EyeGate Pharmaceuticals, Inc.


Posurdex for Retinal Vein Occlusions
PI: Jiong Yan, MD
Coordinator: Jayne M. Brown
Status: No longer enrolling

Summary: The study purpose is to determine the efficacy and safety of Posurdex in the treatment of Branch Retinal and Central Vein Occlusion

Inclusion Criteria:
• Retinal thickness of greater than 300 um by OCT
• Visual decrease from macular edema to 20/50 to 20/200, ETDRS protocol
• 6 wk to 9 mo onset of CRVO
• 6 wk to 12 mo onset of BRVO

Exclusion Criteria:
• Glaucomatous damage or field loss
• Presence of an ocular condition preventing a 15 letter improvement in VA
• Uncontrolled systemic disease
• Diabetic retinopathy

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


AEG211745 for subfoveal CNV
PI: Sunil Srivastava, MD
Coordinator: Jayne Brown
Status: Closed

Summary: A 2 year, phase 2, multicenter, randomized, controlled, masked dose finding trial to assess the efficacy of multiple intravitreal injections of AEG211745 in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Primary response measurement is best corrected visual acuity after 2 years. Randomization is between variable does of AEG211745 and Lucentis.

Inclusion Criteria:
• CNV lesion size ≤ 12 MPS disc areas with 50% active CNV
• BCVA 20/400 to 20/40

Exclusion Criteria:
• Media opacities
• Significant ocular disease in addition to CNV

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


Thymosin Beta 4 for Diabetic Corneal Debridement
PI: Sunil Srivastava, MD
Coordinator: Jayne Brown
Status: Closed

Summary: A randomized, double mask placebo controlled, dose response, phase 2 study of the safety & efficacy of Thymosin Beta 4 in the treatment of diabetic patients’ corneal wounds resulting from epithelial debridement during vitrectomy. TB 4 may enhance healing by helping cells grow back and therefore be a significant treatment advance. 3 dosing groups will be administered post op for 14 days.

Inclusion Criteria:
• Diabetes with Glycosylated hemoglobin 7% - < 12%
• Scheduled vitrectomy

Exclusion Criteria:
• Keratitis
• Intra ocular or anterior segment surgery within 3 months of baseline

Contact: Jayne M. Brown, 404-778-4430
Sponsor: Regene Rx


Oral AEB071 for Uveitis
PI: Sunil Srivastava, MD
Coordinator: Jayne Brown
Status: Enrollment closed

Summary: This study will evaluate an oral immunosuppressant for non-infectious uveitis which may be taken alone or with other uveitis medications. A multicenter, single sequence, open label study to access the tolerability, safety, and efficacy of 2 weeks of oral AEBO71 300 mg twice daily followed by 6 weeks of AEB071 twice daily in treatment of macular edema in patients with non-infectious intermediate uveitis, posterior uveitis or panuveitis.

Inclusion Criteria:
• Macular edema greater than 250 um by Oct.
• Vitreous haze score greater than 1.0 but ≤ 3

Exclusion Criteria:
• Active chorodial neovascularization
• Macular edema associated with other ocular disease

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


A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion (CRUISE)
PI: G. Baker Hubbard, III, MD
Status: Closed.

Summary: To determine safety and efficacy of Ranibizumab (Lucentis) in the treatment of macular edema secondary to Central Retinal Vein Occlusions. This is a 12 month study consisting of 6 months of a “Treatment Period” and the final 6 months being the “Observation Period.” In the Treatment Period, one will receive .3 mg or .5 mg of Ranibizumab, or a sham treatment each month. Treatment is an intravitreal injection for those receiving medication. The sham group gets no medication during this time. In the Observation Period, there is not a sham group. Those on .3 mg continue to receive that dosage and those on .5 mg continue to receive that dosage. The sham group is switched to receive .5 mg during this period. Treatments are given during this period if VA and/or OCT qualifies.

Inclusion Criteria:
• Qualifying visual acuity on two visits within 28 days
• Diagnosis of Central Retinal Vein Occlusion within 12 months

Exclusion Criteria:
• History of laser for macular edema within 4 months prior to first study treatment
• History of intraocular corticosteroid use within 3 months prior to first study treatment
• History of any systemic anti- VEGF or pro-VEGF treatment within 6 months
• Use of oral corticosteroids to treat a chronic condition
• Stroke or heart attack within 3 months

Contact Information: Judy Brower, 404-778-4725
Sponsor: Genentech, Inc.


A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)
PI: G. Baker Hubbard, III, MD
Coordinator: Judy Brower
Study Status: Closed.

Summary:
To determine safety and efficacy of Ranibizumab (Lucentis) in the treatment of macular edema secondary to Branch Retinal Vein Occlusions. This is a 12 month study consisting of 6 months of a “Treatment Period” and the final 6 months being the “Observation Period”. In the Treatment Period, one will receive .3 mg or .5 mg of Ranibizumab, or a sham treatment each month. Treatment is an intravitreal injection for those receiving medication.The sham group gets no medication during this time. There is the possibility of a rescue laser treatment at Month 3, 4, or 5 if certain criteria are met. In the Observation Period, there is not a sham group. Those on .3 mg continue to receive that dosage and those on .5 mg continue to receive that dosage. The sham group is switched to receive .5 mg during this period. Treatments are given during this period if VA and/or OCT qualifies. If rescue laser treatment is needed, it may be given at Month 9, 10, or 11. There can only be one laser treatment given during the Treatment Period and one during the Observation Period.

Inclusion Criteria:
• Qualifying visual acuity on two visits within 28 days
• Diagnosis of Branch Retinal Vein Occlusion within 12 months

Exclusion Criteria:
• History of laser for macular edema within 4 months prior to first study treatment
• History of intraocular corticosteroid use within 3 months prior to first study treatment
• History of any systemic anti VEGF or pro-VEGF treatment within 6 months
• Use of oral corticosteroids to treat a chronic condition
• Stroke or heart attack within 3 months

Contact: Judy Brower, 404-778-4725
Sponsor: Genentech, Inc.


Therasight® Pilot AMD Trial
PI: G. Baker Hubbard III, MD
Coordinator: Alcides Fernandes, MD
Status: This study is closed for enrollment.

Summary: The Emory Eye Center was the first in the United States to use a new system developed by the Theragenics Corporation. This clinical trial was designed to evaluate the safety and feasibility of the new TheraSight® Ocular Brachytherapy System for the treatment of sub-foveal choroidal neovascularization associated with exudative (wet) age-related macular degeneration (AMD). This is a study in which subjects are randomized to one time treatment of one of three doses of radiation applied directly to the sclera behind the macular area. Approximately 20 subjects will take part in this study at up to six clinical sites, Emory Eye Center among them. Favorable results of this study may be used to expand to a larger pivotal trial designed to further test the safety and effectiveness of the TheraSight® System.

Contact: Alcides Fernandes, MD, 404-778-2421
Sponsor: Theragenics Corporation


The Compassionate Use of CNTF Implant for Patients with Retinitis Pigmentosa
PI: Thomas M. Aaberg, MD
Coordinators: Alcides Fernandes, MD; Donna Leef, MMSc, COMT
Status: Enrollment is currently closed. Eleven patients were enrolled in this study.

Summary: This intraocular implant designed by Neurotech USA, of Lincoln, Rhode Island consists of an encapsulated cell technology product which contains the human ciliary neurotrophic factor (CNTF). Neurotrophic factors are agents with a promising ability to retard progression of neurodegenerative diseases and are effective in slowing photoreceptor degeneration in animal models of Retinitis Pigmentosa. In the Phase I safety trial, ten participants received CNTF implants in one eye. Human CNTF was delivered by cells transfected with the human CNTF gene and sequestered within capsules that were surgically implanted into the vitreous of the eye. The implant is designed to continuously release CNTF directly into the eye for sustained period of times. A Phase II study of this technology is currently being conducted in several national medical centers and enrollment is now completed. Emory University was approved to implant a few patients in a compassionate use basis.

Contact: Alcides Fernandes, MD, 404-778-2421, alcides@rmy.emory.edu
Sponsor: Neurotech USA


Age-Related Eye Disease Study 2 (AREDS 2)
PI: G. Baker Hubbard, III, MD
Coordinator: Linda Curtis
Status: Enrollment ended June 30, 2008

Summary: The National Eye Institute (NEI) is sponsoring the 5-year nationwide Age-Related Eye Disease Study2 (AREDS2) to learn what effect nutritional supplementation with Lutein and Zeaxanthin (carotenoids found in many fruits and vegetables) and/or the omega-3 fatty acids DHA and EPA (derived from fish oil)have on the progression to advanced age-related macular degeneration (AMD). AMD is the leading cause of vision loss in the United States for people over the age of 60.

Inclusion Criteria:
• Large drusen in both eyes or
• Large drusen in one eye and advanced AMD in the other eye.

Exclusion Criteria:
• Ocular disease in either eye, other than AMD (glaucoma, etc.)
• Previous retinal or other ocular surgical procedures (except for cataract surgery, YAG capsulotomy, laser or other treatments for advanced AMD).
• Any systemic disease with a limited 5-year survival.

Contact: Linda Curtis, 404-778-4261
Sponsor: NEI

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