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

Summary

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

Timeline

Start

2021-03-12

Primary completion

2025-03-31

Completion

2025-03-31

Outcome

Missed primary endpoint

Stopped: “The primary endpoint was not achieved in the study.”

registry analysis (superiority test); 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 vs 2.0 mg Aflibercept With Sham; p = 0.861409 NCT04757636 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	SOZINIBERCEPT	Protein / enzyme biologic	2 mg	Intravitreal

Indications