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A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
Sponsor: Oculis
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
Conditions
Interventions
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).
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