A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | December 15, 2017 |
| End Date: | June 1, 2019 |
| Contact: | Study Opthea |
| Email: | OPT-302-1003-Clinicaltrial.gov@ppdi.com |
Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema
A two part, multi-center study consisting of a Phase 1b open label, sequential dose
escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating
OPT-302 in combination with aflibercept in participants with persistent central-involved
Diabetic Macular Edema.
escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating
OPT-302 in combination with aflibercept in participants with persistent central-involved
Diabetic Macular Edema.
Inclusion Criteria:
- History of diabetic macular edema (DME) ≤ 2 year
- Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal
response
- Three or more prior anti-VEGF-A therapy intravitreal injections
- EDTRS BCVA score ≤ 73 and ≥ 24 letters
Exclusion Criteria:
- Ocular disorders or ocular treatments which may interfere with assessment of visual
acuity, assessment of toxicity, or fundus photography in the Study Eye
- HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes
- Any clinically significant disorder or condition or disease (e.g. cardiovascular,
renal conditions) that would make the participant unsuitable for the study
We found this trial at
35
sites
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