A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
NCT ID: NCT05066997
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
552 participants
INTERVENTIONAL
2021-10-19
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.
Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OCS-01
dexamethasone ophthalmic suspension,1.5% \[15 mg/ mL\]
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 Vehicle
Placebo is a Vehicle ophthalmic suspension of OCS-01
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening).
1. Have a signed informed consent form before any study-specific procedures are performed.
2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening).
Exclusion Criteria
2. Have a decrease in BCVA because of causes other than DME.
3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oculis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Veeral S Sheth, MD
Role: PRINCIPAL_INVESTIGATOR
University Retina - Lemont
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DX219
Identifier Type: -
Identifier Source: org_study_id