Current Retina Trials

Age-related Macular Degeneration (AMD)
Diabetes
Retinitis Pigmentosa
Retinoblastoma
Uvelitis and Ocular Immunology

Age-related Macular Degeneration (AMD)

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

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.

Clinical Summary:

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

 

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: Chris Bergstrom, 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 75 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

 

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

PI: G. Baker Hubbard, MD
Coordinator: Linda Curtis
Status: Enrolling normal subjects who do not have any signs of age-related macular degeneration (AMD)

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

Exclusion Criteria

Contact: Linda Curtis 404-778-4261

 

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

 

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

 

Retinoblastoma

ARET0332, A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy

PI: G. Baker Hubbard MD
Status: Currently enrolling

Summary: This is a non-randomized study of patients with unilateral retinoblastoma treated with enucleation. The goals are to establish the prevalence of high risk histopathologic features and to demonstrate that patients without these features can be successfully treated with enucleation alone. In addition, the study aims to estimate the event free survival of patients with high risk features who are uniformly treated with adjuvant chemotherapy. Finally the study will estimate the incidence of toxicities associated with the proposed adjuvant chemotherapy.

Inclusion Criteria:
Patients between the ages of 0 and 6 with unilateral retinoblastoma treated with enucleation.

Exclusion Criteria:
Patients treated with any modality other than enucleation are not eligible.

Contact: Gigi Davis 404-785-2319 or Carla Shoffeitt 404-785-1150
Sponsor: Children's Oncology Group

 

Uvelitis and Ocular Immunology

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:
Closed 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

 

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

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: Enrolling

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: Enrolling

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

 

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

 

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

 

Multicenter Uveitis Steroid Treatment (MUST) Trial

PI:  Steven Yeh, MD
Coordinator: Alcides Fernandes, MD
Status: Enrollment 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

 

 

 

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