Clinical trials are designed to test the safety and efficacy of new approaches to preventing, detecting, and treating disease. Clinical trials also look for new ways to use existing treatments, new drugs, surgical procedures and devices.
Participants in clinical trials with Macula Retina Vitreous Research Institute may sign up for screening to check if they are a candidate to receive the newest treatment for their vitreoretinal conditions. Patients involved in clinical research can benefit from additional care and attention from research staff, and will also help researchers find better treatments for future patients.
Active Enrolling Trials
Wet Age-Related Macular Degeneration (wAMD)
ASCENT | AbbVie
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD.
BELVEDERE | Genentech
A Phase IV, Multicenter, Open-Label Study To Assess Corneal Endothelial Cells In Patients with Neovascular Age-Related Macular Degeneration Treated With The Port Delivery System With Ranibizumab (PDS)
Treatment for Wet AMD is highly effective but burdensome for patients who require injections as frequently as every four to eight weeks. In an effort to reduce this burden, Belvedere (a refillable eye implant) was designed to slowly release Lucentis over an extended period of time and only requires refills approximately every six months. This trial will assess changes in vision in patients who switched from previous intraocular injections to the Belvedere implant.
BURGUNDY | Genentech
A Three Part, Phase I/II Study To Investigate The Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following
Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From The Port Delivery In Patients With
Neovascular Age-Related Macular Degeneration
The refillable Port Delivery System is an ocular implant aimed at reducing the burden which nAMD patients face with frequent intravitreal injections. PDS + Lucentis has already shown to be an effective treatment for patients, however, this study will compare PDS + Lucentis to PDS + Zifibancimig at two doses. Zifibancimig is a novel therapeutic developed to inhibit both VEGF-A and Ang-2 with higher affinity and to optimize properties for a long duration of action. Angiopoietin-2 (Ang-2) acts as a vascular destabilization factor, is increased in patients with nAMD, and can be upregulated by VEGF-A. Regulating both VEGF-A and Ang-2 may further normalize the pathological ocular vasculature and provide a more sustained anti-leakage effect, allowing for less frequent dosing.
LUCIA | Eyepoint Pharmaceuticals
A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD
Despite the introduction of a number of improved anti-VEGF biologic agents in recent years, there remains a need for new therapies that will provide equivalent efficacy and anatomic disease control while reducing the need for frequent injections and the burden of mandatory monthly monitoring visits. EyePoint Pharmaceuticals has developed EYP-1901 IVT insert, a sustained and controlled delivery formulation of vorolanib, that releases drug over a period of approximately 6-9 months as a therapy to address this unmet medical need.
Protocol AO | NCT05904028
Home OCT-Guided Treatment versus Treat and Extend for the Management of Neovascular AMD.
Neovascular or “wet” AMD is an ocular disease characterized by the formation of abnormal blood vessel growth that can damage the structural integrity of the macula, a region of the retina responsible for central 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 determine which management approach works best.
If you take part in the study, you will be placed into one of the following two treatment groups: 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.
Geographic Atrophy (GA)
ARCHER II | Annexon Biosciences
A Phase 3, Multicenter, Randomized, Parallel-Group, Double-Masked, 2-Arm, Sham Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
This study aims to reduce vision loss in patients with GA and eligible patients may receive monthly IVT injections of ANX007 or sham for 24 months. ANX007 is an antibody antigen-binding fragment that binds to complement factor C1q and fully inhibits activation of the classical complement pathway. Inhibition of C1q has been shown to be neuroprotective in animal models of photoreceptor cell damage, protecting synapses, neurons and retinal function.
SIENNA | Regeneron
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination with Cemdisiran or Cemdisiran Alone in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (AMD)
This study aims to investigate subcutaneously injected complement C5 inhibition on the growth rate of GA lesions. Pozelimab is an IgG4 antibody, directed against C5 that blocks the formation of the Membrane Attack Complex and therefore mediates cell lysis. Cemdisiran is a livertargeted synthetic siRNA which degrades C5 mRNA and therefore reduces levels of circulating C5 protein. Combining these two agents may lead to a more effective and less burdensome dosing regimen for patients with geographic atrophy. Furthermore, subcutaneous administration may mitigate the need for frequent and bilateral injections.
Diabetic Macular Edema (DME)
THAMES | Genentech
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone Or In Combination with Aflibercept Or Faricimab In Patients With Diabetic Macular Edema
RO7446603 is a multivalent Tie2 receptor agonist designed to activate the Tie2 receptor, which is essential for vascular stability and regulation of angiogenesis. By mimicking or enhancing Angiopoietin-1 activity, it promotes vessel stabilization, reducing leakage and abnormal growth seen in conditions like diabetic macular edema (DME). When used in combination with faricimab—a bispecific antibody targeting VEGF-A and Angiopoietin-2—RO7446603 may enhance therapeutic effects through complementary mechanisms, offering improved vascular normalization and more durable treatment outcomes.
Macular Pucker
Protocol AM | NCT05145491
Randomized Trial Comparing Immediate vs. Deferred Surgery for Symptomatic Epiretinal Membranes (ERM)
Vitrectomy surgery to remove an epiretinal membrane (ERM) is one of the most common procedures performed by retinal specialists. 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 results in worse visual acuity outcomes compared to immediate surgery. 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 attributed to an ERM is distortion of the vision. There are several objective measures of this distortion, but none have been evaluated in a randomized clinical trial, and their usefulness is unknown.
The purpose of this study is to better understand the optimal timing of surgery, to identify predictors of outcomes in those who undergo immediate surgery, to identify predictors of progression in those whose are observed, and to better characterize and evaluate the usefulness of metamorphopsia and reading speed measures.
Upcoming Trials
Dry AMD - Drusolv Therapeutics | OcuStatin
Geographic Atrophy - R3918-AMD-2326 and R3918-AMD-2327
Wet AMD - Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD | ASCENT | NCT05407636
Active Trials (Closed to enrollment)
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 age-related macular degeneration (AMD). Neovascular or “wet” AMD is an ocular disease characterized by the formation of abnormal blood vessel growth that can damage the structural integrity of the macula, a region of the retina responsible for central vision. The main purpose of this study is to assess the efficacy and safety of an investigational medicine known as OPT-302 when used in conjunction with an FDA-approved medication known as ranibizumab. These medications, known as Anti-VEGF therapy, inhibit the proteins responsible for the development of new abnormal vessel growth and subsequent leakage typically found in Wet AMD.
SOL | Ocular Therapeutix
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration (nAMD).
Protocol AN | NCT05727891
A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (DME).
This study is being done to determine if tonabersat, a pill taken by mouth, can help reduce retinal swelling in patients with diabetic macular edema (DME). To evaluate this, participants will be randomized to take either tonabersat or placebo for 6 months.
DME is a manifestation of diabetic retinopathy and the leading cause of moderate vision loss in patients with diabetes. Without intervention, one third of eyes with center-involved DME experienced “moderate visual loss” (defined as a 15 or more letter score decrease in visual acuity) over a three-year period.
While intravitreal anti-VEGF agents have long been the mainstay of care for DME, this treatment is not without its disadvantages including the need for frequent injections, as well as the risk of complications. Thus, there is an ongoing need to identify novel therapies that are both effective for DME treatment and can reduce risks associated with treatment.
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.
