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 1)
NCT05066997 · 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
- 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 |
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 NCT05066997
The ClinicalTrials.gov registry entry for NCT05066997 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 552 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: NCT05066997 reports 20 study locations spanning 7 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05066997?
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 NCT05066997?
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 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
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.