Evaluating OCS-01 Eye Drops for Diabetic Macular Edema
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema
This study is testing whether OCS-01 eye drops can improve vision and safety for people with Diabetic Macular Edema compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Oculis Industry-sponsored |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06172257 on ClinicalTrials.gov |
What this trial studies
This Phase 3 pivotal study aims to assess the efficacy and safety of OCS-01 eye drops compared to a vehicle in patients suffering from Diabetic Macular Edema (DME). The study is designed as a double-masked, randomized, multicenter trial, ensuring that neither the participants nor the investigators know which treatment is being administered. Participants will be monitored for changes in visual acuity and other safety parameters throughout the trial. The study will involve multiple sites, including the Stanford Byers Eye Institute.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Type 1 or Type 2 diabetes who have DME with specific retinal fluid measurements.
Not a fit: Patients whose macular edema is due to causes other than DME or who have significant macular ischemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with Diabetic Macular Edema.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated in a pivotal Phase 3 setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (selection): 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1). Exclusion Criteria (selection): 1. Have macular edema considered to be because of a cause other than DME. 2. Have a decrease in BCVA because of causes other than DME. 3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
Where this trial is running
Palo Alto, California
- Oculis Investigative Site - Stanford Byers Eye Institute — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Diana Do, MD — Stanford Byers Eye Institute
- Study coordinator: Oculis Study Leader
- Email: info@oculis.ocm
- Phone: +41 21 711 3970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.