NCT06172257CompletedPhase 3
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 401 (actual)
- First submitted
- 7 Dec 2023
- Start date
- 15 Mar 2024
- Primary completion date
- 2 Apr 2026
- Lead sponsor
- Oculis
- Diseases
- Diabetic eye disease
- NCT number
- NCT06172257
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 401
- From 15 Mar 2024 to the primary completion date, 2 Apr 2026
- 62 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
Other
- Have macular edema considered to be because of a cause other than DME.
- Have a decrease in BCVA because of causes other than DME.
Who the study is looking for
- Have a signed informed consent form before any study-specific procedures are performed.
- Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
- Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1).
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OFTALMOS, Instituto Oftalmologico de Alta Complejidad Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion Zambrano Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Buenos Aires Macula (BAM) Clinical Research Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro Privado de Ojos Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Organizacion Medica de Investigacion Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro De Ojos Loria Srl Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Charles Centro Oftalmológico Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| Centro Privado de Ojos Romagosa Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Instituto de Microcirugía Ocular Córdoba (IMOC) Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Grupo Láser Visión Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Oftalmologia Global Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro de la Vision Dr. Kolton Coordinator of this site? Confirm its status | Salta | Argentina | Unknown status |
| Rising Retina Clinic Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Narayana Nethralaya Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Lotus Eye Hospital and Institute Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| St. Theresa's Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Agrawal Hospital Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| GSVM Medical College Coordinator of this site? Confirm its status | Kanpur | India | Unknown status |
| Emanuelli Research & Development Center Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Sibia Eye Institute Coordinator of this site? Confirm its status | Boynton Beach | United States | Unknown status |
| Star Retina Coordinator of this site? Confirm its status | Burleson | United States | Unknown status |
| Blue Ocean Clinical Research Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Advanced Research Coordinator of this site? Confirm its status | Coral Springs | United States | Unknown status |
| Retina Specialists of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Erie Retina Research Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Retina Group of Florida Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Charles Retina Institute Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Mid Atlantic Retina Specialists Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| VitreoRetinal Consultants of NY Coordinator of this site? Confirm its status | Hauppauge | United States | Unknown status |
| Houston Eye Associates, North Loop Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Retina Associates of Southern California Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Mississippi Retina Associates Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| East Coast Institute for Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Eye Care Center of Northern Colorado Coordinator of this site? Confirm its status | Longmont | United States | Unknown status |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Marietta Eye Clinic Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Retina Consultants of Southwest Florida Coordinator of this site? Confirm its status | Naples | United States | Unknown status |
| Tennessee Retina Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Illinois Retina Associates Coordinator of this site? Confirm its status | Oak Park | United States | Unknown status |
| Stanford Byers Eye Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Georgia Retina Coordinator of this site? Confirm its status | Peachtree City | United States | Unknown status |
| Vision Research Solutions in Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Retinal Consultants of Arizona - Phoenix North Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Austin Retina Associates Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Retinal Consultants Medical Group, Inc. Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| San Antonio Eye Center - Downtown Clinic Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Medical Center Ophthalmology Associates Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
| Island Retina Coordinator of this site? Confirm its status | Shirley | United States | Unknown status |
| Macula Retina Vitreous Center Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Tyler Retina Consultants Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| Vitreoretinal Consultants of NY Coordinator of this site? Confirm its status | Westbury | United States | Unknown status |
| Palmetto Retina Center Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.