The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)
OMEGA
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
1 other identifier
interventional
198
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 11, 2007
CompletedFirst Posted
Study publicly available on registry
June 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedApril 2, 2008
March 1, 2008
2.7 years
June 11, 2007
March 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the area of GA
2 years
Study Arms (3)
1
EXPERIMENTALOT-551 0.3% ophthalmic solution
2
EXPERIMENTALOT-551 0.45% ophthalmic solution
3
PLACEBO COMPARATORvehicle placebo
Interventions
Eligibility Criteria
You may qualify if:
- have a clinical diagnosis of GA in one or both eyes;
- be of non-childbearing potential
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Oxnard, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Boynton Beach, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Novi, Michigan, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Lakewood, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 11, 2007
First Posted
June 13, 2007
Study Start
June 1, 2007
Primary Completion
February 1, 2010
Last Updated
April 2, 2008
Record last verified: 2008-03