OPT-302 With Ranibizumab 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); 0.5 mg Ranibizumab With Standard Dosing 2.0 mg OPT-302 vs 0.5 mg Ranibizumab With Sham; p = 0.284421; Least Squares Mean Difference -1.10 NCT04757610 ↗

registry analysis (superiority test); 0.5 mg Ranibizumab With Extended Dosing 2.0 mg OPT-302 vs 0.5 mg Ranibizumab With Sham; p = 0.066678; Least Squares Mean Difference -1.88 NCT04757610 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal
Subject	SOZINIBERCEPT	Protein / enzyme biologic	2 mg	Intravitreal

Indications