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Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

Macular Edema Clinical Trial

Official title:
A Multicenter, Open-label, Safety and Proof-of-concept Study to Assess Safety, Tolerability and Efficacy of AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03739593
Study type Interventional
Source Aerie Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date March 13, 2019
Completion date July 9, 2020
View Details
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