General Information
The Retina Institute participates in numerous national studies recognizing that medical research lies at the core of clinical advancements. These studies are used to assist in the diagnosis, prevention and treatment of various retinal diseases. Clinical trials help establish if new treatments, new drugs, or new surgical procedures are safe and effective.
Participation in a clinical trial is an important decision and should be discussed with a physician. Enrollment in a study possibly means receiving the newest management and care for a disease or illness. Participants often join to help others with the same condition by assisting researchers in their efforts to find better treatments. These trials offer future hope for many people with sight-threatening conditions.
Clinical trials in the U.S. must follow strict protocol and be registered with The National Institute of Health (NIH). A listing of these studies can be found in the clinicaltrials.gov database.
AMEND
Pathology: High Risk Intermediate Age-Related Macular Degeneration (AMD) or Small Lesion Geographic Atrophy (GA)
Description: A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing the Safety and Efficacy of AQ102 in Subjects with dry AMD
Study Objectives: To evaluate the efficacy of QA102 oral capsules on the development/progression of geographic atrophy and/or development of CNV in patients with intermediate to small lesion advanced dry AMD.
Principal Investigator: Dr. Dang
Status: Open Enrollment
AMYDIS (OLIX)
Pathology: Wet Age-Related Macular Degeneration (AMD)
Description: A Phase 1, Multicenter, Open-Label, Single- and Multi-Dose, Dose-Escalating Clinical Study to Evaluate the Safety and Tolerability of OLX10212 Administered by Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration
Study Objectives: The primary objective is to evaluate the safety and tolerability of single and multiple intravitreal injection(s) of OLX10212 in patients with neovascular AMD.
Principal Investigator: Dr. Papakostas
Status: Open Enrollment
COAST
Pathology: Neovascular Age-Related Macular Degeneration (nAMD)
Description: A Phase 3, multicentre, double-masked, randomized study to evaluate the efficacy and safety of intravitreal OPT-302 in combination with aflibercept, between changes in retina function with the severity of diabetic retinopathy.
Study Objectives: To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD
Principal Investigator: Dr. Blinder
Status: Open Enrollment
DRCR AF
Pathology: Non-Proliferative Diabetic Retinopathy (NPDR)
Description: A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
Study Objectives: To assess the ability of oral Fenofibrate to prevent progression of Diabetic Retinopathy in an at risk population (mild to moderately-severe NPDR). Despite improved glycemic control for many patients, Diabetic Retinopathy progresses in a large majority of patients
Principal Investigator: Dr. Durrani
Status: Open Enrollment
DRCR AJ
Pathology: Macular Hole (MH)
Description: Vitreous Proteomics in Eyes with a Macular Hole
Study Objectives: Verify and characterize abnormally expressed vitreous proteins in adults with full thickness macular holes (MH) versus vitreous from a floaterectomy control group.
Principal Investigator: Dr. Blinder
Status: Open Enrollment
DRCR AM
Pathology: Epiretinal Membrane (ERM)
Description: Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes
Study Objectives: To better understand the optimal timing of surgical intervention for the best visual result, quantify metamorphopsia, and evaluate post surgical progression of ERM.
Principal Investigator: Dr. Blinder
Status: Open Enrollment
JANSSEN GENE THERAPY TRIAL
Pathology: Geographic Atrophy (GA)
Description: A Phase 2/3, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD).
Study Objectives: Change in GA lesion growth of eyes treated with JNJ-81201887 compared to sham control: Change in square root GA lesion area in the study eye measured on FAF.
Principal Investigator: Dr. Blinder
Status: Open Enrollment
NHOR (Natural History Observation Registry)
Pathology: Macular Telangiectasia type 2 (MacTel 2)
Description: World-wide registry of individuals with Macular Telangiectasia type 2, and their family members. in the registry involves an initial clinic visit with a comprehensive eye exam, and blood is drawn for MacTel research.
Study Objectives: The Lowy Medical Research Institute is to determine if MacTel has a genetic component. Blood drawn at registry sites is banked for by scientists affiliated with LMRI.
Status: Open Enrollment
Principal Investigator: Dr. Blinder
ONL1204-RRD-002 – ONL THERAPEUTICS
Pathology: Macula-off Rhegmatogenous Retinal Detachment
Description: A Phase 2, Randomized, Sham-Controlled, Single-Masked, Dose Ranging, Multi-Center Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects with Macula-off Rhegmatogenous Retinal Detachment
Study Objectives: To evaluate the safety and efficacy of two doses (50 μg and 200 μg) of a single intravitreal injection of ONL1204 Ophthalmic Solution as an adjunct to standard-of-care and changes in contrast sensitivity and BCVA.
Principal Investigator: Dr. Durrani
Status: Open Enrollment
REZOLUTE Study – Rezolute Inc.
Pathology: Diabetic Macular Edema
Description: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ402 in Participants with Diabetic Macular Edema
Study Objectives: To assess the repeat-dose safety and tolerability of once daily administration of oral medication RZ402 along with changes in CST from baseline.
Principal Investigator: Dr. Blinder
Status: Open Enrollment
TEJAS/ASHVATTHA THERAPEUTICS
Pathology: Neovascular (wet) Age-Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
Description: A Two Stage Phase 2 Study: Stage 1: Single Subcutaneous Dose Open-label Assessment of Safety and Pharmacodynamic Response to D-4517.2 (hydroxyl dendrimer VEGFR tyrosine kinase inhibitor) in subjects with Neovascular (wet) Age-Related Macular Degeneration (AMD) or subjects with Diabetic Macular Edema (DME).
Study Objective: To evaluate the safety and tolerability of a single subcutaneous (SC) dose of D-4517.2 in subjects with neovascular (wet) AMD and subjects with DME.
Principal Investigator: Dr. Dang
Status: Open Enrollment