A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

NCT03397264 PHASE1, PHASE2 COMPLETED Results posted

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.

Details

Lead sponsor	Opthea Limited
Phase	PHASE1, PHASE2
Status	COMPLETED
Enrolment	153
Start date	Tue Jan 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jun 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Diabetic Macular Edema

Interventions

• Aflibercept
• OPT-302
• Sham intravitreal injection

Countries

Israel, United States, Australia, Latvia