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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 16 (62 locations)

    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