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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
Must not have
Have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy
Had confounding ocular surgery in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with GA in at least one eye.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had abnormal blood vessel growth in my eye.
Select...
I have had eye surgery that could affect the study results.
Select...
My eye condition won't worsen during the study and affect my vision.
Select...
I am not on any medication known to harm the eye.
Select...
My vision loss is not due to AMD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
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Who is running the clinical trial?
Othera PharmaceuticalsLead Sponsor
3 Previous Clinical Trials
223 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had abnormal blood vessel growth in my eye.I have had eye surgery that could affect the study results.I am not on any medication known to harm the eye.I have been diagnosed with GA in at least one eye.My eye condition won't worsen during the study and affect my vision.My vision loss is not due to AMD.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
- Group 3: 3
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