Brolucizumab in Neovascular Age-Related Macular Degeneration - Indian Real-World Experience: The BRAILLE Study - Fifty-Two- Week Outcomes

Abstract

Purpose: To report the 52-week real-world efficacy and safety outcomes of brolucizumab therapy for neovascular age-related macular degeneration (nAMD) in Indian eyes. Patients and Methods: A retrospective, multicentre chart analysis of 82 eyes of 82 patients with nAMD (switch therapy: 65 eyes; treatment-naïve: 17 eyes) with 52-week follow-up data was performed. Pro-re-nata re-treatment was offered based on visual and tomographic criteria. Changes in best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central-subfield thickness (CST), and pigment epithelial detachment (PED) were the key outcome measures, coupled with the safety profile. Results: The mean age of the study population was 67.65 (±10.67) years, with 57 male patients (69.5%). The study’s mean number of injections was 4.8 (± 0.77). After brolucizumab therapy, the BCVA improved significantly at weeks 4 (P<0.001), and maintained up to week 52 (P<0.001). The CST also reduced significantly at all the visits (Baseline: 413.6 ± 64.6 µm; 52-week: 292.37 ± 13.5 µm; P<0.001). Significantly fewer eyes demonstrated residual SRF (P<0.001) and IRF (P<0.001) at all visits, starting with week 12 and continuing until week 52. The PED resolution was significant from week 24 through week 52 (P=0.004). Each of the 82 eyes received four injections of brolucizumab, with 63.4% (52 eyes) receiving a fifth dose and only 17.1% requiring a sixth. Mild intraocular inflammation (IOI) was seen in three eyes (3.66%) that resolved conservatively. One patient (1.2%) developed mild fever that subsided with oral medications. Conclusion: The 52-week BRAILLE study demonstrates that brolucizumab is effective and safe in nAMD eyes in a real-world setting. Brolucizumab treatment can reduce the therapeutic burden in patients with nAMD due to its rapid, sustained efficacy and favourable safety profile.