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OT-551 Eye Drops for Age-Related Macular Degeneration (OMEGA Trial)

Phase 2
Waitlist Available
Research Sponsored by Othera Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a clinical diagnosis of GA in one or both eyes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

OMEGA Trial Summary

This trial is testing whether two doses of OT-551 can safely and effectively treat geographic atrophy associated with age-related macular degeneration.

Who is the study for?
This trial is for adults who have been diagnosed with geographic atrophy due to age-related macular degeneration (Dry AMD) in one or both eyes. Participants should not be able to bear children and must not need contact lenses during the study. They cannot join if they've had certain eye surgeries, poor vision in the non-study eye, a history of specific eye conditions, or are on medications that could harm their eyes.Check my eligibility
What is being tested?
The OMEGA Study is testing two different doses of OT-551 eye drops against a drug-free solution to see which is safer and more effective for treating geographic atrophy associated with Dry AMD. Patients will receive either the active treatment or placebo.See study design
What are the potential side effects?
Potential side effects from OT-551 are not detailed here but may include typical reactions related to ophthalmic solutions such as irritation, discomfort, redness, or allergic reactions. The vehicle placebo typically has no active ingredients but can cause similar mild local side effects.

OMEGA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with GA in at least one eye.

OMEGA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the area of GA

OMEGA Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2Experimental Treatment1 Intervention
OT-551 0.45% ophthalmic solution
Group II: 1Experimental Treatment1 Intervention
OT-551 0.3% ophthalmic solution
Group III: 3Placebo Group1 Intervention
vehicle placebo

Find a Location

Who is running the clinical trial?

Othera PharmaceuticalsLead Sponsor
3 Previous Clinical Trials
223 Total Patients Enrolled

Media Library

OT-551 Ophthalmic Solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00485394 — Phase 2
Age-Related Macular Degeneration Research Study Groups: 1, 2, 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have joined this medical experiment?

"At this juncture, the trial is not taking on any additional patients. It was initially posted to clinicaltrials.gov in June 2007 and last updated March 2008. If you would like alternative studies, there are currently 319 trials searching for participants with atrophy and one looking for individuals suitable for OT-551 intervention."

Answered by AI

In what geographical context is this experiment conducted?

"This clinical trial is presently taking place at 18 different medical facilities, including Lakewood, Portland and Boynton Beach. To reduce travel burden, it's recommended that patients select the closest clinic to them as a possible site for their involvement in this study."

Answered by AI

Is this new trial a pioneering endeavor?

"At present, Othera Pharmaceuticals is running a single OT-551 trial across 18 cities and 1 nation. This pioneering study began in 2007 and included 198 participants. Subsequently, the drug achieved successful Phase 2 approval before undergoing additional trials since then."

Answered by AI

Has the federal government sanctioned OT-551 for public consumption?

"While efficacy data is still pending, the safety of OT-551 has been supported by prior clinical evidence and consequently earned a score of 2."

Answered by AI

Has research been conducted regarding OT-551 in the past?

"OT-551 was initially evaluated in 2007 (NCT00485394). To date, one trial has concluded and there is now a single study actively being conducted near Lakewood, Ohio."

Answered by AI

Are there any vacant positions for participants in this research?

"At this moment, the study is not recruiting participants. Initially posted on June 1st 2007 and last updated March 31st 2008, if you are looking for alternative studies to join there are currently 319 clinical trials searching for volunteers with atrophy and one (1) trial of OT-551 actively enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)
2007. "The OMEGA Study: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration (Dry AMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00485394.
All > Age Related Macular Degeneration > Geographic Atrophy
~11 spots leftby Apr 2025
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