Overview

Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)

Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oculis
Collaborator:
ICON plc
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
Criteria
Inclusion Criteria (selection):

1. Have a signed informed consent form before any study-specific procedures are
performed.

2. 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).

3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤
10.0% prior to screening (Visit 1).

Exclusion Criteria (selection):

1. Have macular edema considered to be because of a cause other than DME.

2. Have a decrease in BCVA because of causes other than DME.

3. Have a known history of significant macular ischemia which would prevent gain in
visual acuity in the study eye.