This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO). A more durable intravitreal implant containing a low dose of dexamethasone may result in less frequent retreatments, and potentially lower the incidence of steroid-related side effects without compromising efficacy.
AR-1105 is a dexamethasone containing implant drug delivery system that is injected into the back of the eye. It is designed to dissolve slowly over time, continuously releasing a consistent low dose of steroid to treat the symptoms of RVO and associated inflammation with a goal of halting further visual disturbance and damage, and also possibly restoring some vision as symptoms are controlled. In this study, 2 different formulations are being tested to find the optimum combination of efficacy, safety and durability that will offer patients a potential treatment option that is as safe and effective as the treatments currently available, but which requires less frequent injections and potentially has a lower risk for certain side-effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
AR-1105 clinical formulation 1 (AR-1105-CF1)
AR-1105 clinical formulation 2 (AR-1105-CF2)
Retinal Research Institute, LLC
Phoenix, Arizona, United States
Retina Vitreous Associates
Beverly Hills, California, United States
Byers Eye Institute at Stanford
Palo Alto, California, United States
Safety Tolerability: Number of Ocular and Non-ocular TEAEs
Treatment-emergent adverse events summarized at the subject level by system organ class and preferred term are available in the Adverse Events module. Data reported in the table below corresponds to the total number of participants with ocular and non-ocular treatment-emergent adverse events (TEAEs).
Time frame: Up to 6 months treatment duration
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Florida Eye Clinic
Altamonte Springs, Florida, United States
Center for Retina & Macular Disease
Lakeland, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Mid-Atlantic Retina
Cherry Hill, New Jersey, United States
Cleveland Clinic- Cole Eye Institute
Cleveland, Ohio, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Texas Retina Associates
Arlington, Texas, United States
...and 1 more locations