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NCT05066997 · ClinicalTrials.gov registry record · Phase 2
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
A Phase 2 study of Diabetic Macular Edema, sponsored by Oculis.
- Active
- Registry status
- Phase 2
- Development phase
- 552
- Enrollment target
- 20
- Study locations
NCT05066997: Active Phase 2 study of Diabetic Macular Edema, sponsored by Oculis.
NCT05066997 is a Phase 2 study of Diabetic Macular Edema that is active but no longer recruiting, run by Oculis. The registered enrollment target is 552 participants, below the 3,786-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05066997, a Phase 2 study of Diabetic Macular Edema, is active but no longer recruiting, sponsored by Oculis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 552 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
- Retina-Vitreous Associates Medical Group - Beverly Hills
- The Retina Partners - Encino
- Retinal Consultants Medical Group - Modesto
- California Eye Specialists Medical Group - Pasadena
- California Eye Specialists Medical Group - Redlands
- Retina Consultants of Southern California - Redlands
- California Retina Consultants - Santa Maria
Florida
- Rand Eye Institute - Deerfield Beach
- Florida Retina Institute - Jacksonville
- MedEye Associates - Miami
- Florida Retina Institute - Orlando
- Retina Care Specialists - Palm Beach Gardens
- East Florida Eye Institute - Stuart
Arizona
- Arizona Retina and Vitreous Consultants - Phoenix
- Phoenix Retina Associates - Phoenix
Illinois
- Retina Associates - Elmhurst
- University Retina - Lemont
Arkansas
- Retina Partners of Northwest Arkansas - Springdale
Connecticut
- Retina Group Of New England - Waterford
Georgia
- Southeast Retina Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 552 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT05066997 still lists
NCT05066997 is an interventional study that assigns participants to a tested intervention. The registered 552 participants enrollment target is mid-sized for trials with a published cap, below the 3,786-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (85% 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.
NCT05066997 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05066997 about?
NCT05066997 is a clinical study titled "A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)". 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 NCT05066997?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 552 participants. The study started on 2021-10-19. Estimated completion is 2026-04.
What conditions does trial NCT05066997 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT05066997?
The interventions under investigation include: Vehicle (DRUG), Dexamethasone ophthalmic suspension (OCS-01) (DRUG).
Who is sponsoring clinical trial NCT05066997?
This trial is sponsored by Oculis, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05066997 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. 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 NCT05066997's enrollment target sits among peer trials
552 8th of 63 higher than 56 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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