Brolucizumab Versus Aflibercept in Participants With Neovascular Age-Related Macular Degeneration: A Randomized Trial
Dugel PU, Jaffe GJ, Sallstig P, et al
This prospective, randomized, double-masked, phase 2 multicenter study compared the efficacy and safety of brolucizumab with that of aflibercept in treatment-naive patients with neovascular age-related macular degeneration (AMD). The primary endpoint of the study was to demonstrate noninferiority between brolucizumab and aflibercept.
The study enrolled 90 patients, 83 of whom completed the study.
Patients were assigned 1:1 to receive either brolucizumab (6 mg/50 µL) or aflibercept (2 mg/50 µL).
There were three treatment periods throughout the study. For the induction phase, all patients received monthly injections at weeks 0, 4, and 8 and were assessed at week 12. The second study period consisted of every-8-week injections at weeks 16, 24, and 32, with assessment at week 40. In the third treatment period, brolucizumab patients received injections every 12 weeks (at weeks 48 and 56), while the aflibercept patients continued on an every-8-week injection schedule (with treatments at weeks 40 and 48). Additionally, the study examined how many patients needed rescue injections during the loading and every-8-week treatment periods.
The study met its primary endpoint, as it showed brolucizumab was noninferior to aflibercept in change in visual acuity between baseline and at weeks 12 and 16. The study also demonstrated similar decreases in central foveal thickness at weeks 12 and 16 for both brolucizumab and aflibercept. Of note, at week 40, the proportion of eyes without both subretinal fluid and intraretinal fluid for brolucizumab and aflibercept was 61% and 35%, respectively. There was also a difference in the number of patients who needed additional unscheduled treatments. Five patients in the brolucizumab group needed six additional unscheduled treatments versus 15 unscheduled treatments in 10 patients in the aflibercept group.
Medscape Ophthalmology © 2017 WebMD, LLC
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Cite this: Matt R. Starr, Sophie J. Bakri. New Anti-VEGF Agent Brolucizumab Shows Promise for AMD - Medscape - Oct 12, 2017.