Clinical trials are designed to test the safety and efficacy of new approaches to preventing, detecting, and treating disease. Research and clinical trials also continuously look for new ways to use existing treatments, new drugs, surgical procedures and devices.
Macula Retina Vitreous Research Institute clinical trial participants may enroll to possibly receive the newest treatment for their vitreoretinal conditions, as well as to have additional care and attention from clinical trial staff and with the results and outcome of their trial, help researchers find better treatments for future patients.
Active Enrolling Trials
Wet AMD – Study of OPT-302 in Combination with Ranibizumab (ShORe) Phase 3 Trial | OPT-302-1004 | Opthea
We are pleased to announce our involvement in a Phase 3 clinical research study offered to select participants with Neovascular AMD. Neovascular or “wet” AMD is an ocular disease characterized by the formation of new abnormal vessel growth that can damage the structural integrity of the macula, a central region of the retina responsible for central vision. The main purpose of this study is to investigate the efficacy and safety of an investigational medicine known as intravitreal OPT-302 when used in conjunction with an FDA approved medication known as ranibizumab. These medications are also known as Anti-VEGF therapy which inhibit the proteins responsible for the development of new abnormal vessel growth and subsequent leakage typically found in Wet AMD.
Learn More on Opthea
Learn More on ClinicalTrials.gov
Macular Pucker – Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic Epiretinal Membranes (ERM) | Protocol AM | NCT05145491
Vitrectomy to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal surgeons. Patients who present with significant macular changes on optical coherence tomography (OCT) but relatively good vision are often advised to defer surgery until vision declines to 20/40 or worse. However, it is unknown if delaying surgery, which allows the foveal architecture to remain compromised and potentially to deteriorate, results in worse visual acuity outcomes than if surgery is performed earlier. In addition, there is a need to better understand predictors of outcomes when surgery is performed and predictors of progression when surgery is deferred. Finally, one of the most common presenting symptoms from an ERM is distortion or metamorphopsia. There are several objective measures of metamorphopsia, but none have been employed to evaluate ERMs in a randomized clinical trial (RCT) and their usefulness is unknown. The purposes of this study are to better understand the optimal timing of surgery to produce the best visual result, to better understand predictors of outcomes in those who undergo surgery and predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures. This is a multi-facility, nationwide study conducted by DRCR Retina Network.
Learn More on ClinicalTrials.gov
Learn More on JAEB.org
Diabetic Retinopathy – A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (DME) | Protocol AN | NCT05727891
The study is being done to determine if tonabersat, a pill taken by mouth, can help retinal swelling go away for patients with central retinal swelling (diabetic macular edema, or DME) and good vision. Participants will be randomly assigned to take either tonabersat or placebo for 6 months to see how tonabersat affects DME. A final visit will happen in 12 months.
DME is a manifestation of diabetic retinopathy and the leading cause of moderate vision loss in patients with diabetes. Without intervention, 33% of the 221 eyes included in the Early Treatment Diabetic Retinopathy Study (ETDRS) with center-involved DME (CI-DME) experienced “moderate visual loss” (defined as a 15 or more letter score decrease in visual acuity) over a three-year period. (www.kambioeyewear.com)
Results of the DRCR Retina Network Protocol I (Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema) indicated that treatment with anti-vascular endothelial growth factor (anti-VEGF) agents was superior to that of focal/grid laser (both alone and combined with intravitreous corticosteroids) in the management of DME.
While subsequent studies have confirmed this superiority further with different anti-VEGF agents, this treatment is not without its disadvantages including the need for recurrent injections as often as once a month, and the injections themselves having potentially serious side effects such as the development of endophthalmitis. Intravitreal injections are also associated with high incremental cost effectiveness ratios and additionally, not all eyes treated with anti-VEGF have resolution, needing other interventions such as laser, a treatment with well-documented adverse events. Thus, there is an ongoing need to identify novel therapies that are both effective for DME treatment and that also avoid potential adverse events or costs associated with current ocular interventions.
Learn More on ClinicalTrials.gov
Learn More on JAEB.org
Wet AMD – Home OCT-Guided Treatment versus Treat and Extend for the Management of Neovascular AMD | Protocol AO | NCT05904028
Neovascular AMD, also known as ‘wet’ AMD, is a disease in which abnormal blood vessels grow in the back of your eye. These blood vessels cause buildup of fluid in your eye, which can damage the central part of your eye (called the macula) and lead to central vision loss. The macula is the part of the retina used for sharp, straight-ahead vision. The goal of this study is to compare outcomes from two different management approaches for neovascular AMD. We will collect information on both approaches to help doctors and their patients determine the best management approach.
If you take part in the study, you will have a 50:50 chance of receiving one of the following two approaches: 1) Anti-VEGF injections based on Treat and Extend monitoring (standard of care treatment) approach, 2) Anti-VEGF injections based on Home OCT-guided monitoring approach.
These groups are referred to as ‘Treat and Extend’ and ‘Home OCT’ respectively. You will know which treatment you are receiving. If you are in the Home OCT group, you will be asked to take daily scans of your eyes using the Home OCT device for two years.
Learn More on ClinicalTrials.gov
Learn More on JAEB.org
Upcoming Trials
Wet AMD – Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD | ASCENT | NCT05407636
Wet AMD – Genentech | Belvedere
Dry AMD – Drusolv Therapeutics | OcuStatin
Geographic Atrophy – R3918-AMD-2326 and R3918-AMD-2327
Retinal Vein Occlusion – Regeneron | Quantum
Active Trials (Closed to enrollment)
Dry AMD – A decentralized epidemiological study of the progression of Age-related Macular Degeneration (AMD) | Character Bio
AMD has a large genetic component; 34 common genetic variants have been discovered that are associated with AMD. A weighted polygenic risk score can classify an individuals’ total level of genetic risk, and have some power to predict disease progression, in combination with environmental and clinical risk factors. Individuals with high genetic risk but don’t progress to advanced disease may have protective genetic variants. This is an epidemiologic study. There are no risks in participating in this study, as there is no administration of new medications.