Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
NCT06172257 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 401 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oculis, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06172257 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06172257?
The interventions under investigation include: Vehicle (DRUG), Dexamethasone ophthalmic suspension (OCS-01) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06172257?
This trial is sponsored by Oculis, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.