NCT04757636

OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 998 (actual)
• Sponsor: Opthea Limited · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	2.0 mg OPT-302	intravitreal injection
BIOLOGICAL	2.0 aflibercept	intravitreal injection
PROCEDURE	Sham	intravitreal injection

Timeline

• Start date: 2021-03-12
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2021-02-17
• Last updated: 2025-08-05
• Results posted: 2025-08-05

Locations

209 sites across 30 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Netherlands, Philippines, Poland, Puerto Rico, Slovakia, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study