A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

Phase 3

Active, not recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Dexamethasone ophthalmic suspension (OCS-01); Drug: Vehicle

• Registration Number: NCT06172257
• Lead Sponsor: Oculis

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

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-03-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-08
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OCS-01	Dexamethasone ophthalmic suspension (OCS-01)	dexamethasone ophthalmic suspension,1.5% \[15 mg/mL\]
Vehicle ophthalmic suspension	Vehicle	Vehicle of OCS-01

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)	Week 52	Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a 3-line or Greater Gain in BCVA	Baseline, Week 52	BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Mean Change in BCVA	Baseline, Week 12 and Week 24	BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Mean Change in Central Subfield Thickness (CST)	Baseline, Week 52	CST will be measured by spectral domain optical coherence tomography (SD-OCT)

Trial Locations

Locations (60)

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States

Retinal Consultants of Arizona - Phoenix North; 🇺🇸 Phoenix, Arizona, United States

California Retina Consultants; 🇺🇸 Santa Barbara, California, United States

Retina Associates of Southern California; 🇺🇸 Huntington Beach, California, United States

Stanford Byers Eye Institute; 🇺🇸 Palo Alto, California, United States

Retinal Consultants Medical Group, Inc; 🇺🇸 Sacramento, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

Macula Retina Vitreous Center; 🇺🇸 Torrance, California, United States

Retina Specialists of Colorado; 🇺🇸 Denver, Colorado, United States

Eye Care Center of Northern Colorado; 🇺🇸 Longmont, Colorado, United States

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