Evaluating OCS-01 Eye Drops for Diabetic Macular Edema

A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema

This study is testing if OCS-01 eye drops can help people with Diabetic Macular Edema feel better and improve their vision over a year.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 497 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Oculis (industry)
• Locations: 1 site (Lemont, Illinois)
• Trial ID: NCT05066997 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of OCS-01 eye drops in patients with Diabetic Macular Edema (DME). It consists of two stages: the first stage focuses on selecting an appropriate dosing regimen and evaluating the treatment's effects at 12 weeks, while the second stage continues to assess efficacy and safety at 52 weeks. Participants will be randomly assigned to receive either the OCS-01 treatment or a vehicle control. The study is designed to provide robust data on the potential benefits of OCS-01 for managing DME.

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 characteristics.

Not a fit: Patients whose macular edema is caused by factors other than diabetes may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from Diabetic Macular Edema.

How similar studies have performed: Other studies have shown promise with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria (selection) - Stage 1:

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 central subfield thickness (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 at Visit 1 (Screening).

Inclusion Criteria (selection) - Stage 2:

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 central subfield thickness (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 Visit 1 (Screening).

Exclusion criteria (selection) - Stage 1 and Stage 2:

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

Lemont, Illinois

• Oculis Investigative Site: University Retina - Lemont — Lemont, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Veeral S Sheth, MD — University Retina - Lemont
• Study coordinator: Oculis Study Leader

Conditions: Diabetic Macular Edema, Topical ophthalmic suspension, Eye drop