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

Deependra Vikram Singh; Aniruddha Agarwal; Anubhav Goyal; Daraius Shroff; Jatinder Singh; Pradeep Kumar; Raja Rami Reddy; Ramesh Venkatesh; Shilpi Narnaware; Shrinivas Joshi; Deependra V Singh; Ritesh Narula; Aishwarya Joshi; Aniruddha Agarwal; Anubhav Goyal; Charu Gupta; Daraius Shroff; Giridhar Anantharaman; Jatinder Singh; Pradeep Kumar; Prashant Bawankule; Raja Rami Reddy; Rajiv Jain; Ramesh Venkatesh; Ruchir Tiwari; Shalini Sugumar; Shashank Rai Gupta; Shilpi Narnaware; Shrinivas Joshi; Somendra P Choudhary; Delhi Retina Forum Study Group

doi:10.4103/IJO.IJO_757_24

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

Deependra Vikram Singh^*
, Aniruddha Agarwal
, Anubhav Goyal
, Daraius Shroff
, Jatinder Singh
, Pradeep Kumar
, Raja Rami Reddy
, Ramesh Venkatesh
, Shilpi Narnaware
, Shrinivas Joshi
, Deependra V Singh
, Ritesh Narula
, Aishwarya Joshi
, Aniruddha Agarwal
, Anubhav Goyal
, Charu Gupta
, Daraius Shroff
, Giridhar Anantharaman
, Jatinder Singh
, Pradeep Kumar

Prashant Bawankule, Raja Rami Reddy, Rajiv Jain, Ramesh Venkatesh, Ruchir Tiwari, Shalini Sugumar, Shashank Rai Gupta, Shilpi Narnaware, Shrinivas Joshi, Somendra P Choudhary, Delhi Retina Forum Study Group

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Pages (from-to)	1786-1794
Number of pages	9
Journal	Indian Journal of Ophthalmology
Volume	72
Issue number	12
DOIs	https://doi.org/10.4103/IJO.IJO_757_24
Publication status	Published - 29 Nov 2024

Keywords

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

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10.4103/IJO.IJO_757_24Licence: CC BY-NC-SA

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Singh, D. V., Agarwal, A., Goyal, A., Shroff, D., Singh, J., Kumar, P., Reddy, R. R., Venkatesh, R., Narnaware, S., Joshi, S., Singh, D. V., Narula, R., Joshi, A., Agarwal, A., Goyal, A., Gupta, C., Shroff, D., Anantharaman, G., Singh, J., ... Delhi Retina Forum Study Group (2024). Initial experience with brolucizumab for neovascular age-related macular degeneration (nAMD) in India - Multicentric, real-world study. Indian Journal of Ophthalmology, 72(12), 1786-1794. https://doi.org/10.4103/IJO.IJO_757_24

@article{9c25e087a37c4fd18d5dce99ca95e15c,

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

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.",

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

author = "Singh, \{Deependra Vikram\} and Aniruddha Agarwal and Anubhav Goyal and Daraius Shroff and Jatinder Singh and Pradeep Kumar and Reddy, \{Raja Rami\} and Ramesh Venkatesh and Shilpi Narnaware and Shrinivas Joshi and Singh, \{Deependra V\} and Ritesh Narula and Aishwarya Joshi and Aniruddha Agarwal and Anubhav Goyal and Charu Gupta and Daraius Shroff and Giridhar Anantharaman and Jatinder Singh and Pradeep Kumar and Prashant Bawankule and Reddy, \{Raja Rami\} and Rajiv Jain and Ramesh Venkatesh and Ruchir Tiwari and Shalini Sugumar and Gupta, \{Shashank Rai\} and Shilpi Narnaware and Shrinivas Joshi and Choudhary, \{Somendra P\} and \{Delhi Retina Forum Study Group\}",

year = "2024",

month = nov,

day = "29",

doi = "10.4103/IJO.IJO\_757\_24",

language = "English",

volume = "72",

pages = "1786--1794",

journal = "Indian Journal of Ophthalmology",

issn = "0301-4738",

publisher = "Wolters Kluwer Medknow Publications",

number = "12",

}

Singh, DV, Agarwal, A, Goyal, A, Shroff, D, Singh, J, Kumar, P, Reddy, RR, Venkatesh, R, Narnaware, S, Joshi, S, Singh, DV, Narula, R, Joshi, A, Agarwal, A, Goyal, A, Gupta, C, Shroff, D, Anantharaman, G, Singh, J, Kumar, P, Bawankule, P, Reddy, RR, Jain, R, Venkatesh, R, Tiwari, R, Sugumar, S, Gupta, SR, Narnaware, S, Joshi, S, Choudhary, SP & Delhi Retina Forum Study Group 2024, 'Initial experience with brolucizumab for neovascular age-related macular degeneration (nAMD) in India - Multicentric, real-world study', Indian Journal of Ophthalmology, vol. 72, no. 12, pp. 1786-1794. https://doi.org/10.4103/IJO.IJO_757_24

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 -

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

Abstract

Keywords

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