NCT03397264

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

Phase 1b/2a Study of OPT-302 in Combination With Aflibercept for Persistent Central-involved Diabetic Macular Edema

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Opthea Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study OPT-302-1003 was designed as a 2-part, multicenter study consisting of a Phase 1b open-label, sequential dose escalation followed by a Phase 2a randomized, parallel-group, sham-controlled, double-masked, dose-expansion evaluating intravitreal OPT-302 in combination with aflibercept in participants with persistent central-involved diabetic macula edema.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
BIOLOGICAL	Aflibercept	Intravitreal injection
BIOLOGICAL	OPT-302	Intravitreal Injection
OTHER	Sham intravitreal injection	Sham (mock) intravitreal injection

Timeline

• Start date: 2018-01-16
• Primary completion: 2020-03-26
• Completion: 2020-06-11
• First posted: 2018-01-11
• Last updated: 2025-04-22
• Results posted: 2022-06-22

Locations

53 sites across 4 countries: United States, Australia, Israel, Latvia

Regulatory

• FDA-regulated drug study