Initial experience with brolucizumab for neovascular age-related macular degeneration (nAMD) in India - Multicentric, real-world study

Indian J Ophthalmol. 2024 Dec 1;72(12):1786-1794. doi: 10.4103/IJO.IJO_757_24. Epub 2024 Nov 29.

Abstract

Purpose: To evaluate the anatomic and visual outcomes and safety profile of initial Indian eyes with neovascular age-related macular degeneration (nAMD) treated with intravitreal injection (IVI) of brolucizumab.

Methods: This retrospective multicentric, real-world study enrolled consecutive eyes with nAMD that were treated with IVI brolucizumab after it was launched in India in October 2020. Data collected for each eye included best-corrected visual acuity (BCVA), central subfield thickness (CSFT), subretinal fluid (SRF), and intraretinal fluid (IRF) status at 6, 12, and 24 months follow-up. Also recorded were the lens status, treatment protocol, number of injections received before enrollment (in switch-over cases), total number of injections, and adverse effects noticed during the study period. Primary outcomes were change in BCVA, CSFT at follow-up visits, and incidence of intraocular inflammation (IOI). Secondary outcomes were profile of macular neovascularization, treatment protocols, mean number of injections, and maximum injection-free interval observed in eyes treated by pro-re-nata (PRN) protocol.

Results: In total, 331 eyes received a mean of 3.55 ± 1.83 injections. Most frequent treatment protocol was PRN (53%). BCVA data was available for 100%, 96%, and 74% eyes at 6, 12, and 24 months follow-up. BCVA and CSFT improved significantly (P < 0.001) at all follow-ups. Two hundred and seventy-six (83.38%) out of 331 eyes received more than one injection; out of these, 241 (87.3%) eyes that were treated by PRN protocol could achieve mean "maximum injection-free interval" of 19.43 ± 8.82 weeks. IOI and retinal vasculitis were reported in 2.11% (7/331) and 0.60% (2/331) eyes, respectively. None of the eyes with IOI or vasculitis lost any vision at the final follow-up.

Conclusion: This study demonstrated favorable visual and anatomic outcomes and safety profile for eyes with nAMD treated by IVI brolucizumab. Mean maximum injection-free interval in eyes treated with PRN was 19 weeks.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Female
  • Fluorescein Angiography / methods
  • Follow-Up Studies
  • Fundus Oculi
  • Humans
  • India / epidemiology
  • Intravitreal Injections*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Tomography, Optical Coherence* / methods
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Visual Acuity*
  • Wet Macular Degeneration* / diagnosis
  • Wet Macular Degeneration* / drug therapy
  • Wet Macular Degeneration* / physiopathology

Substances

  • Angiogenesis Inhibitors
  • brolucizumab
  • Antibodies, Monoclonal, Humanized
  • Vascular Endothelial Growth Factor A