TY - JOUR
T1 - Initial experience with brolucizumab for neovascular age-related macular degeneration (nAMD) in India - Multicentric, real-world study
AU - Singh, Deependra Vikram
AU - Agarwal, Aniruddha
AU - Goyal, Anubhav
AU - Shroff, Daraius
AU - Singh, Jatinder
AU - Kumar, Pradeep
AU - Reddy, Raja Rami
AU - Venkatesh, Ramesh
AU - Narnaware, Shilpi
AU - Joshi, Shrinivas
AU - Singh, Deependra V
AU - Narula, Ritesh
AU - Joshi, Aishwarya
AU - Agarwal, Aniruddha
AU - Goyal, Anubhav
AU - Gupta, Charu
AU - Shroff, Daraius
AU - Anantharaman, Giridhar
AU - Singh, Jatinder
AU - Kumar, Pradeep
AU - Bawankule, Prashant
AU - Reddy, Raja Rami
AU - Jain, Rajiv
AU - Venkatesh, Ramesh
AU - Tiwari, Ruchir
AU - Sugumar, Shalini
AU - Gupta, Shashank Rai
AU - Narnaware, Shilpi
AU - Joshi, Shrinivas
AU - Choudhary, Somendra P
AU - Delhi Retina Forum Study Group
PY - 2024/11/29
Y1 - 2024/11/29
N2 - 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.
AB - 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.
KW - Humans
KW - Intravitreal Injections
KW - Male
KW - India/epidemiology
KW - Retrospective Studies
KW - Female
KW - Angiogenesis Inhibitors/administration & dosage
KW - Visual Acuity
KW - Aged
KW - Wet Macular Degeneration/drug therapy diagnosis physiopathology
KW - Tomography, Optical Coherence/methods
KW - Follow-Up Studies
KW - Antibodies, Monoclonal, Humanized/administration & dosage therapeutic use
KW - Treatment Outcome
KW - Fluorescein Angiography/methods
KW - Vascular Endothelial Growth Factor A/antagonists & inhibitors
KW - Middle Aged
KW - Fundus Oculi
KW - Aged, 80 and over
U2 - 10.4103/IJO.IJO_757_24
DO - 10.4103/IJO.IJO_757_24
M3 - Article
SN - 0301-4738
VL - 72
SP - 1786
EP - 1794
JO - Indian Journal of Ophthalmology
JF - Indian Journal of Ophthalmology
IS - 12
ER -