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.

  • 4FRONT-1 (GENE THERAPY)

Pathology: Treatment Naïve nAMD

Description: A phase 3, randomized, double-masked, active-controlled trial of a singular intravitreal injection of 4D-150 in adults with macular neovascularization secondary to age-related macular degeneration

 

  • ARTEMIS (GENE THERAPY)

Pathology: Treatment Naïve nAMD

Description: A multi-center, randomized, double-masked, active-comparator-controlled, phase 3 study to evaluate the efficacy and safety of Ixoberogene Soroparvovec (Ixo-vec) in participants with neovascular age-related macular degeneration

 

  • BETTIS-1/ECLIPSE – ANTI VEGF POOR RESPONDER DME

Pathology: Diabetic Macular Edema

Description: A randomized, controlled, subject and evaluator-masked, phase 2, clinical trial comparing EC-104 intravitreal implant to Ozurdex for the treatment of diabetic macular edema

 

  • BP41670/ BURGUNDY

Pathology: nAMD

Description: A phase 1/2a study evaluating the safety, tolerability, and efficacy of zifbancimig for treating neovascular age-related macular degeneration (nAMD)

 

  • BP45482

Pathology: Fovea involved Geographic Atrophy

Description: A phase I, multi-center, multi-part study to investigate safety, tolerability, PK, PD, and immunogenicity of RO7669330 intravitreal injections in participants with GA secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD PILOT; Part 2: Masked, randomized, active-comparator-controlled

  • DAYBREAK

Pathology: Treatment Naïve nAMD

Description: A prospective, randomized, double-masked, active comparator-controlled, multicenter, three-arm phase 3 study to evaluate the efficacy and safety of intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer compared with intravitreal Aflibercept in participants with neovascular (Wet) age-related macular degeneration (wAMD)

  • DRCR AF

Pathology: Diabetic Retinopathy

Description: A randomized trial evaluating Fenofibrate for prevention of diabetic retinopathy worsening

 

  • DRCR AL

Pathology: Radiation Retinopathy

Description: A randomized clinical trial evaluating intravitreal Faricimab injections or Fluocinolone Acetonide intravitreal implants vs. observation for prevention of visual acuity due to radiation retinopathy

 

  • DRCR AM

Pathology: Epiretinal Membranes

Description: A randomized trial comparing immediate versus deferred surgery for symptomatic epiretinal membranes

  • DRCR AO

Pathology: Neovascular AMD

Description: A home OCT-guided treatment versus treat and extend for the management of neovascular AMD

 

  • DRCR GENES

Pathology:  Any DRCR Enrolled Patient

Description: The DRCR.net is pursuing this genetics initiative to collect, store, analyze, and distribute genetic material with accompanying phenotypic information. The initiative will provide a unique opportunity to combine data from multiple populations, to define genetic factors that confer risk for development and progression of diabetic retinopathy and other retinal diseases, and response to therapeutic intervention.

  • GR44251 (STEM CELL)

Pathology: Fovea Involved Geographic Atrophy

Description: A phase 2a multicenter, open-label, single-arm study to optimize subretinal surgical deliver and to evaluate safety and activity of Opregen in patients with geographic atrophy secondary to age-related macular degeneration

 

  •  IHEEZO vs. SUBCONJUNCTIVAL LIDOCAINE IST

Pathology: Intravitreal Injection Pain

Description: Comparing intravitreal injection pain scores using Iheezo (Chloroprocaine HCl ophthalmic gel 3%) versus subconjunctival Lidocaine (2%): A randomized, controlled trial

 

  • OCU410ST-101/301 (GENE THERAPY)

Pathology: Stargardt’s Disease

Description: A phase 1 study to assess the safety and efficacy of OCU410ST for Stargardt Disease and phase 2/3 pivotal confirmatory clinical trial to assess the safety and efficacy of OCU410ST for Stargardt Disease

 

  • PREGONDA BP44175

Pathology: Diabetic Macular Edema

Description: A phase I, multipart, multicenter study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7497372 following intravitreal administration in participants with diabetic macular edema (Part 1 non-randomized, open-label, multiple ascending dose, Part 2 randomized, double-masked)

 

  • R3918-AMD-2297/SIENNA

Pathology: Geography Atrophy

Description: A phase 3 study investigating the use of experimental drugs pozelimab and cemdisiran for treating geographic atrophy (GA)