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Corticosteroid
OCS-01 Eye Drops for Macular Edema
Phase 3
Recruiting
Led By Diana Do, MD
Research Sponsored by Oculis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1).
Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
Must not have
Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
Have macular edema considered to be because of a cause other than DME.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial
Summary
This trial looks at an eye treatment to help people with diabetes-related vision problems.
Who is the study for?
This trial is for individuals with Diabetic Macular Edema (DME), a condition where blood vessels leak into the retina causing swelling. Participants should have this specific eye condition to qualify.
What is being tested?
The study is testing OCS-01, a dexamethasone ophthalmic suspension, against a placebo (Vehicle) to see if it's more effective and safe in treating DME when applied as eye drops.
What are the potential side effects?
Potential side effects of OCS-01 may include increased pressure inside the eye, cataract formation, and possible risk of infections or allergic reactions from the eye drops.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have diabetes with an HbA1c of 10% or less.
Select...
My eye condition involves fluid buildup and a central retinal thickness of 310 µm or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of severe eye blood flow problems that could affect my vision.
Select...
My macular edema is not due to diabetic macular edema.
Select...
My vision loss is not due to diabetic macular edema.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change from baseline in BCVA (Best Corrected Visual Acuity)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OCS-01Experimental Treatment1 Intervention
dexamethasone ophthalmic suspension,1.5% \[15 mg/mL\]
Group II: Vehicle ophthalmic suspensionPlacebo Group1 Intervention
Vehicle of OCS-01
Find a Location
Who is running the clinical trial?
ICON plcIndustry Sponsor
87 Previous Clinical Trials
28,531 Total Patients Enrolled
OculisLead Sponsor
8 Previous Clinical Trials
1,337 Total Patients Enrolled
Diana Do, MDPrincipal InvestigatorStanford Byers Eye Institute
2 Previous Clinical Trials
126 Total Patients Enrolled
Arshad Khanani, MDPrincipal InvestigatorSierra Eye Associates
5 Previous Clinical Trials
730 Total Patients Enrolled