Clinical Ophthalmology (Aug 2023)
Short-Term Treatment Outcomes of Brolucizumab in Patients with Neovascular Age-Related Macular Degeneration: A Multicentre Indian Real-World Evidence Study
Abstract
Debdulal Chakraborty,1 Milan Thakkar,2 Ramesh Venkatesh,3 Sangeeta Roy,4 Maulik Bhavsar,5 Helene Karcher6 1Disha Eye Hospital, Kolkata, West Bengal, India; 2Dr. Milan’s Retina Care Centre, Rajkot, Gujarat, India; 3Narayana Nethralaya, Bangalore, Karnataka, India; 4Susrut Eye Foundation and Research Centre, Kolkata, West Bengal, India; 5Novartis Healthcare Pvt. Ltd., Mumbai, Maharashtra, India; 6Novartis Pharma AG, Basel, SwitzerlandCorrespondence: Debdulal Chakraborty, Disha Eye Hospital, Kolkata, West Bengal, India, Email [email protected]: To evaluate the short-term effectiveness and safety outcomes following brolucizumab treatment in patients with neovascular age-related macular degeneration (nAMD) as a part of real-world clinical practice in India.Methods: This was a retrospective, observational, multicentre study including patients (≥ 50 years old) diagnosed with nAMD. Anonymized data of the patients receiving the first dose of brolucizumab intravitreal injection (IVI) who were either treatment-naïve or previously treated with a single or a combination of other anti-VEGF IVIs were included. The present study reported the change in retinal fluid levels from baseline to month 3, best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of injections received. The adverse events in the three months after brolucizumab treatment initiation were also monitored.Results: The study included 63 patients (65 eyes) from four study centres across India (mean age: 69.1 ± 9.7 years). A total of 82 brolucizumab injections were administered during the 3 months of study duration, with 52/65 (80.0%) eyes receiving only 1 injection. Resolution of IRF, SRF, and PED was observed in 76.9%, 64.6%, and 67.7% of eyes, respectively. Further, a significant reduction in CRT was observed (baseline: 403.5 ± 118.7 μm; month 3: 308.3 ± 73.8 μm; p < 0.001), and BCVA also improved notably from 0.7 ± 0.5 logMAR at baseline to 0.5 ± 0.4 logMAR at month 3 (p < 0.001). Adverse events (AEs) were reported in 3 eyes from 3 patients; retinal pigment epithelial rip (1) and subretinal hemorrhage (2) after the first injection of brolucizumab, however, none discontinued the treatment.Conclusion: The study reports on the short-term effectiveness and tolerability of brolucizumab therapy in the management of nAMD in both treatment-naïve and switch eyes. Brolucizumab was observed to have a favourable benefit-risk profile, and study results were within the known safety profile, with no instances of intraocular inflammation.Keywords: anti-VEGF, brolucizumab, nAMD, real-world evidence, India
