Assessing OCU200 for Diabetic Macular Edema
A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema
This study is testing a new treatment called OCU200 to see if it can help people with diabetic macular edema while keeping them safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ocugen Industry-sponsored |
| Locations | 5 sites (Deerfield Beach, Florida and 4 other locations) |
| Trial ID | NCT05802329 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study evaluates the safety and efficacy of OCU200 in patients with center-involved diabetic macular edema (DME). It is a multicenter, open-label trial that employs a dose-escalation design with three cohorts receiving varying doses of OCU200, and an additional cohort receiving OCU200 in combination with Lucentis. The study aims to enroll up to 28 participants, with a focus on monitoring safety data through a Data Safety Monitoring Board (DSMB). Participants will receive intravitreal injections of OCU200 at low, medium, or high doses based on their cohort assignment.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Type 1 or Type 2 Diabetes Mellitus who have decreased visual acuity due to center-involved DME.
Not a fit: Patients with uncontrolled hypertension, glaucoma, or other concurrent eye diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve visual acuity and quality of life for patients suffering from diabetic macular edema.
How similar studies have performed: Other studies have shown promise with anti-VEGF therapies for DME, suggesting potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus 2. Decreased visual acuity attributable primarily to DME 3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of: 1. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis 2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus 4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart 5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging 6. No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year. Note: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye. Exclusion Criteria: 1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage) 2. Uncontrolled hypertension 3. Uncontrolled glaucoma 4. Concurrent disease in the study eye, other than central-involved DME 5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit 6. Any ocular surgery within 3 months prior to the screening visit in the study eye 7. Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%) 8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye 9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit 10. Presence of any inherited retinal disease or history of proliferative diabetic retinopathy 11. History of Renal disease including stage 3b or worse
Where this trial is running
Deerfield Beach, Florida and 4 other locations
- Advanced Research LLC — Deerfield Beach, Florida, United States (Recruiting)
- Erie Retina Research, LLC — Erie, Pennsylvania, United States (Recruiting)
- Retina Consultants of Texas Research Centers — Bellaire, Texas, United States (Recruiting)
- Retina Consultants of America — Southlake, Texas, United States (Recruiting)
- Gundersen Health System — La Crosse, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Roshan A George, MD, MPH
- Email: roshan.george@ocugen.com
- Phone: 845-664-1505
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.