drugset / Trial / NCT03397264
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2018-01-16
- Primary completion
- 2020-03-26
- Completion
- 2020-06-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SOZINIBERCEPT | Protein / enzyme biologic | 0.3 mg | Intravitreal |
| Subject | SOZINIBERCEPT | Protein / enzyme biologic | 1 mg | Intravitreal |
| Subject | SOZINIBERCEPT | Protein / enzyme biologic | 2 mg | Intravitreal |
| Background | Aflibercept | Protein / enzyme biologic | 2 mg | Intravitreal |