The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with age-related macular degeneration.

Detailed Description
-----------------
Age-related macular degeneration (AMD) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. The vast majority of AMD patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (RPE). Dry AMD may remain static or progress slowly to produce areas of geographic atrophy (GA), the advanced or late-stage form of dry AMD. GA is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. Currently, there is no approved treatment for dry AMD or GA. Pre-clinical results have shown that OT-551 may protect RPE cells and photoreceptors from oxidative damage and block angiogenesis stimulated by VEGF and other growth factors, and therefore is a therapeutic candidate for treating GA.

Official Title
-----------------
A Randomized, Double-Masked, Dose-Ranging, Multi-Center, Phase II Study Comparing the Safety and Efficacy of OT-551 With Placebo to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: OT-551
* Drug: OT-551
* Drug: vehicle placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have a clinical diagnosis of GA in one or both eyes; be of non-childbearing potential Exclusion Criteria: have GA secondary to any condition other than AMD in the study eye; have a BCVA of 20/200 or worse in the non-study eye; have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy; have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study; need to wear contact lenses in the study eye during the study; had confounding ocular surgery in the study eye; have concomitant treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, or optic nerve;

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>OT-551 0.3% ophthalmic solution | Drug: OT-551<br>* OT-551 0.3% ophthalmic solution, 2 drops 4 times daily<br>|
| Experimental: 2<br>OT-551 0.45% ophthalmic solution | Drug: OT-551<br>* OT-551 0.45% ophthalmic solution, 2 drops 4 times daily<br>|
| Placebo Comparator: 3<br>vehicle placebo | Drug: vehicle placebo<br>* OT-551 0% ophthalmic solution, 2 drops 4 times daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the area of GA |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, age-related macular degeneration, geographic atrophy, GA