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A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
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 2/3 Double-Masked, Randomized, 2 Stage, 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
552
Start Date
2021-10-19
Completion Date
2026-04
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone ophthalmic suspension (OCS-01)
Stage 1: 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 6 weeks (maintenance phase). Stage 2: 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
Stage 1: 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 6 weeks (maintenance phase). Stage 2: Participant 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 (52)
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
Phoenix Retina Associates
Phoenix, Arizona, United States
Retina Partners of Northwest Arkansas
Springdale, Arkansas, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Retinal Consultants Medical Group
Modesto, California, United States
California Eye Specialists Medical Group
Pasadena, California, United States
California Eye Specialists Medical Group
Redlands, California, United States
Retina Consultants of Southern California
Redlands, California, United States
California Retina Consultants
Santa Maria, California, United States
Retina Group Of New England
Waterford, Connecticut, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Florida Retina Institute
Jacksonville, Florida, United States
MedEye Associates
Miami, Florida, United States
Florida Retina Institute
Orlando, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
East Florida Eye Institute
Stuart, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Retina Associates
Elmhurst, Illinois, United States
University Retina
Lemont, Illinois, United States
Midwest Eye Institute
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Retina Consultants of Minnesota
Saint Louis Park, Minnesota, United States
The Retina Institute
St Louis, Missouri, United States
Retina-Vitreous Surgeons of Central New York
Liverpool, New York, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Velocity (Meridian) Clinical Research
Cincinnati, Ohio, United States
Verum Research LLC
Eugene, Oregon, United States
Vision Research Solutions in Philadelphia
Philadelphia, Pennsylvania, United States
Retina Consultants of Charleston
Beaufort, South Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Retina Consultants of Austin/Austin Research Center for Retina
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Center of Texas
Grapevine, Texas, United States
Valley Retina Institute PA d.b.a. Gulf Coast Eye Institute
McAllen, Texas, United States
Tyler Retina Consultants
Tyler, Texas, United States
Strategic Clinical Research Group
Willow Park, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
HKU Eye Centre
Hong Kong, Hong Kong
Chinese University of Hong Kong Eye Centre
Kowloon, Hong Kong
Shivam Retina Clinic and Eye Hospital
Surat, Gujarat, India
Nethra Eye Hospital
Bengaluru, Karnataka, India
Amrita Institute of Medical Sciences & Research Centre
Kochi, Kerala, India
Sarakshi Netralaya
Nagpur, Maharashtra, India
L V Prasad Eye Institute
Bhubaneswar, Odisha, India
ICARE Eye Hospital & Post Graduate Institute
Noida, Uttar Pradesh, India
Changhua Christian Hospital
Changhua, Changhua, Taiwan
China Medical University Hospital
Taichung, Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, Taoyuan, Taiwan