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NCT06172257 · ClinicalTrials.gov registry record · Phase 3
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
A Phase 3 study of Diabetic Macular Edema, sponsored by Oculis.
- Active
- Registry status
- Phase 3
- Development phase
- 401
- Enrollment target
- 20
- Study locations
NCT06172257: Active Phase 3 study of Diabetic Macular Edema, sponsored by Oculis.
NCT06172257 is a Phase 3 study of Diabetic Macular Edema that is active but no longer recruiting, run by Oculis. The registered enrollment target is 401 participants, below the 3,788-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06172257, a Phase 3 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by Oculis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 401 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Dexamethasone ophthalmic suspension (OCS-01)
Study Locations (20)
California
- California Retina Consultants - Bakersfield
- Retina Associates of Southern California - Huntington Beach
- Stanford Byers Eye Institute - Palo Alto
- Retinal Consultants Medical Group, Inc - Sacramento
- Retinal Consultants Medical Group - Sacramento
- California Retina Consultants - Santa Barbara
- Macula Retina Vitreous Center - Torrance
Florida
- Sibia Eye Institute - Boynton Beach
- Blue Ocean Clinical Research - Clearwater
- Advanced Research - Coral Springs
- Retina Group of Florida - Fort Lauderdale
- East Coast Institute for Research - Jacksonville
- Retina Consultants of Southwest Florida - Naples
Arizona
- Associated Retina Consultants - Gilbert
- Associated Retina Consultants - Phoenix
- Retinal Consultants of Arizona - Phoenix North - Phoenix
Colorado
- Retina Specialists of Colorado - Denver
- Eye Care Center of Northern Colorado - Longmont
Georgia
- Marietta Eye Clinic - Marietta
- Georgia Retina - Peachtree City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 401 participants |
| Start Date | 2024-03-15 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT06172257 still lists
NCT06172257 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 3,788-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT06172257 names 20 study sites across 5 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06172257 about?
NCT06172257 is a clinical study titled "A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)". 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).
What is the current status of trial NCT06172257?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 401 participants. The study started on 2024-03-15. Estimated completion is 2026-04.
What conditions does trial NCT06172257 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT06172257?
The interventions under investigation include: Vehicle (DRUG), Dexamethasone ophthalmic suspension (OCS-01) (DRUG).
Who is sponsoring clinical trial NCT06172257?
This trial is sponsored by Oculis, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06172257 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06172257's enrollment target sits among peer trials
401 11th of 63 higher than 53 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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