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ACTIVE NOT RECRUITING
NCT06172257
PHASE3

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

Sponsor: Oculis

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

401

Start Date

2024-03-15

Completion Date

2026-04

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone ophthalmic suspension (OCS-01)

Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

DRUG

Vehicle

Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).

Locations (62)

Associated Retina Consultants

Gilbert, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

Retinal Consultants of Arizona - Phoenix North

Phoenix, Arizona, United States

California Retina Consultants

Bakersfield, 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

California Retina Consultants

Santa Barbara, 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

Sibia Eye Institute

Boynton Beach, Florida, United States

Blue Ocean Clinical Research

Clearwater, Florida, United States

Advanced Research

Coral Springs, Florida, United States

Retina Group of Florida

Fort Lauderdale, Florida, United States

East Coast Institute for Research

Jacksonville, Florida, United States

Retina Consultants of Southwest Florida

Naples, Florida, United States

Marietta Eye Clinic

Marietta, Georgia, United States

Georgia Retina

Peachtree City, Georgia, United States

Illinois Retina Associates

Oak Park, Illinois, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Mississippi Retina Associates

Jackson, Mississippi, United States

Sierra Eye Associates

Reno, Nevada, United States

VitreoRetinal Consultants of NY

Hauppauge, New York, United States

Island Retina

Shirley, New York, United States

Vitreoretinal Consultants of NY

Westbury, New York, United States

Erie Retina Research

Erie, Pennsylvania, United States

Vision Research Solutions in Philadelphia

Philadelphia, Pennsylvania, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina

Nashville, Tennessee, United States

Retina Consultants of Texas

Bellaire, Texas, United States

Star Retina

Burleson, Texas, United States

Houston Eye Associates, North Loop

Houston, Texas, United States

Austin Retina Associates

Round Rock, Texas, United States

San Antonio Eye Center - Downtown Clinic

San Antonio, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Tyler Retina Consultants

Tyler, Texas, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Fundacion Zambrano

Buenos Aires, Buenos Aires, Argentina

Oftalmos - Instituto Oftalmológico de Alta Complejidad

Buenos Aires, Buenos Aires, Argentina

Centro De Ojos Loria Srl

CABA, Buenos Aires, Argentina

Centro Privado de Ojos

CABA, Buenos Aires, Argentina

Organizacion Medica De Investigacion

CABA, Buenos Aires, Argentina

Buenos Aires Macula (BAM) Clinical Research

CABA, Buenos Aires, Argentina

Charles Centro Oftalmológico

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Centro Privado de Ojos Romagosa

Córdoba, Córdoba Province, Argentina

Instituto de Microcirugía Ocular Córdoba (IMOC)

Córdoba, Córdoba Province, Argentina

Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital

Mendoza, Mendoza Province, Argentina

Centro de la Vision Dr. Kolton

Salta, Salta Province, Argentina

Grupo Laser Vision

Rosario, Santa Fe Province, Argentina

Oftalmologìa Global

Rosario, Santa Fe Province, Argentina

Rising Retina Clinic

Ahmedabad, Gujarat, India

Narayana Nethralaya

Bangalore, Karnataka, India

Agrawal Hospital

Jaipur, Rajasthan, India

Lotus Eye Hospital and Institute

Coimbatore, Tamil Nadu, India

St. Theresa's Hospital

Hyderabad, Telangana, India

GSVM Medical College

Kanpur, Uttar Pradesh, India

Emanuelli Research & Development Center

Arecibo, Puerto Rico