Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-2)

Phase 3

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 is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).

Detailed Description

A Phase 3 Pivotal Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-03-15
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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 EDTRS chart representing better visual acuity

Trial Locations

Locations (1)

Oculis Investigative Site - Stanford Byers Eye Institute; 🇺🇸 Palo Alto, California, United States