Status:
ACTIVE_NOT_RECRUITING
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
Lead Sponsor:
Oculis
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).
Detailed Description
A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema
Eligibility Criteria
Inclusion
- Inclusion Criteria (selection):
- Have a signed informed consent form before any study-specific procedures are performed.
- 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).
- Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1).
- Exclusion Criteria (selection):
- Have macular edema considered to be because of a cause other than DME.
- Have a decrease in BCVA because of causes other than DME.
- Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
Exclusion
Key Trial Info
Start Date :
March 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT06172257
Start Date
March 15 2024
End Date
April 1 2026
Last Update
December 19 2025
Active Locations (62)
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1
Associated Retina Consultants
Gilbert, Arizona, United States, 85297
2
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
3
Retinal Consultants of Arizona - Phoenix North
Phoenix, Arizona, United States, 85053
4
California Retina Consultants
Bakersfield, California, United States, 93309