Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06172257
The ClinicalTrials.gov registry entry for NCT06172257 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 401 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,788-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (89% lower). The listed sponsor is Oculis, which has 8 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
-
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
RECRUITING · Phase 3
-
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
RECRUITING · Phase 3
-
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
ACTIVE NOT RECRUITING · Phase 3
-
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
ACTIVE NOT RECRUITING · Phase 3
-
A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.