Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Phase 3 Completed 517 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy and safety of brolucizumab vs. aflibercept in the treatment of patients with visual impairment due to diabetic macular edema (DME).

Timeline

Start: 2019-07-17
Primary completion: 2021-03-24
Completion: 2021-03-24

Outcome

Met primary endpoint

paper Brolucizumab was noninferior to aflibercept in best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letter score) change from baseline at week 52 PMID 37971723 ↗

paper difference, 1.1; 95% CI, -0.6 to 2.9; noninferiority margin, 4; P < .001 PMID 37971723 ↗

Publications

Singh RP, Barakat MR, Ip MS, Wykoff CC, Eichenbaum DA, Joshi S, Warrow D, Sheth VS, Stefanickova J, Kim YS, He F, Cho GE, Wang Y, Emanuelli A. Efficacy and Safety of Brolucizumab for Diabetic Macular Edema: The KINGFISHER Randomized Clinical Trial. JAMA Ophthalmol. 2023 Dec 1;141(12):1152-1160. doi: 10.1001/jamaophthalmol.2023.5248.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	Brolucizumab	Other / unclassified	6 mg	Intravitreal