IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD

Phase 2 Completed 128 enrolled Jeffrey S Heier Regeneron Pharmaceuticals · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

This is a prospective, single-blind, randomized study to evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in "high-risk" subjects.

Timeline

Start: 2015-06
Primary completion: 2019-03
Completion: 2019-03

Outcome

Missed primary endpoint

paper the rates of conversion were not lower in the IAI group compared with the sham treatment group at month 24. PMID 33734306 ↗

paper By month 24, 6 patients (9.5%) in the IAI group and 7 (10.9%) in the sham group developed eAMD (P = .98). PMID 33734306 ↗

Publications

Heier JS, Brown DM, Shah SP, Saroj N, Dang S, Waheed NK, Wykoff CC, Prenner JL, Boyer DS. Intravitreal Aflibercept Injection vs Sham as Prophylaxis Against Conversion to Exudative Age-Related Macular Degeneration in High-risk Eyes: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 May 1;139(5):542-547. doi: 10.1001/jamaophthalmol.2021.0221.

Drugs

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