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Corticosteroid

Dexamethasone Eye Drops for Diabetic Macular Edema

Phase 2 & 3
Recruiting
Led By Veeral S Sheth, 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 a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening)
Be older than 18 years old
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 stage 1: week 6; stage 2: week 52

Summary

This trial is testing a new eye drop for people with diabetic macular edema. The goal is to see if it is effective and safe.

Who is the study for?
This trial is for individuals with type 1 or type 2 diabetes who have diabetic macular edema (DME), a condition causing swelling in the retina. Participants must have an HbA1c of ≤12.0% and retinal swelling confirmed by specific eye scans. It's not for those whose DME has other causes, significant macular ischemia, or vision loss from non-DME issues.
What is being tested?
The study tests OCS-01 (dexamethasone) eye drops against a placebo (vehicle) to see if they're safe and effective for treating DME. Patients will be randomly assigned to receive either the active treatment or placebo.
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 in the eye due to its steroid component.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have diabetes with an HbA1c level of 12.0% or lower.

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 affect my vision.
Select...
My macular edema is not due to diabetic macular edema.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 1: week 6; stage 2: week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and stage 1: week 6; stage 2: week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean change in BCVA (Best Corrected Visual Acuity)
Secondary study objectives
Safety measures

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 placebo armPlacebo Group1 Intervention
Vehicle ophthalmic suspension

Find a Location

Who is running the clinical trial?

ICON plcIndustry Sponsor
87 Previous Clinical Trials
28,384 Total Patients Enrolled
Syneos HealthOTHER
176 Previous Clinical Trials
68,176 Total Patients Enrolled
OculisLead Sponsor
8 Previous Clinical Trials
1,190 Total Patients Enrolled
Veeral S Sheth, MDPrincipal InvestigatorUniversity Retina - Lemont
David S. Boyer, MDStudy ChairRetina-Vitreous Associates Medical Group
1 Previous Clinical Trials
65 Total Patients Enrolled
David JacobsStudy DirectorOculis
Suk Jin Moon, MDPrincipal InvestigatorCenter for Retina and Macular Disease, Winter Haven, FL
Albert Edwards, MDPrincipal InvestigatorVerum Research, LLC, Eugene, OR
David Boyer, MDPrincipal InvestigatorRetina-Vitreous Associates Medical Group, Beverly Hills, CA
3 Previous Clinical Trials
47 Total Patients Enrolled
Allen Hu, MDPrincipal InvestigatorCumberland Valley Retina Consultants, Hagerstown, MD

Media Library

OCS-01 (dexamethasone) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05066997 — Phase 2 & 3
Diabetic Macular Edema Research Study Groups: OCS-01, Vehicle placebo arm
Diabetic Macular Edema Clinical Trial 2023: OCS-01 (dexamethasone) Highlights & Side Effects. Trial Name: NCT05066997 — Phase 2 & 3
OCS-01 (dexamethasone) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05066997 — Phase 2 & 3
~154 spots leftby Jun 2026
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