Brolucizumab in Neovascular Age-Related Macular Degeneration – Indian Real-World Experience: The BRAILLE Study

Abstract

Purpose: To assess the short-term efficacy and safety profile of intravitreal brolucizumab injection in Indian eyes with neovascular age-related macular degeneration (nAMD) under real-world conditions. Patients and Methods: This was a multicenter, retrospective chart review of 94 eyes of 94 patients with nAMD (treatment-naïve and switch-therapy) undergoing brolucizumab therapy. Re-treatment as per pro-re-nata protocol was performed based on fixed visual and tomographic criteria. The main outcome measures were changes in the best-corrected visual acuity (BCVA), intraretinal fluid (IRF), subretinal fluid (SRF), central subfield thickness (CST), and pigment epithelial detachment (PED) along with safety analysis. Results: Of the 94 eyes, 20 eyes (21.3%) were treatment-naïve, whereas the rest 74 eyes (78.7%) underwent switch therapy. One hundred and twenty-six injections were given over a mean followup of 7.3 ± 2.2 (range 5-30) weeks. The BCVA improved significantly from 0.82 ± 0.5 LogMAR at baseline to 0.66 ± 0.5 LogMAR at the final visit (p < 0.0001). Significant reduction in CST was simultaneously noted (Baseline: 408.45 ± 65.63 µm; Final: 281.14 ± 37.74 µm; p < 0.0001). On qualitative analysis, resolution of subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment (PED) was observed in 15.5%, 39.29%, and 23.81% of the eyes, respectively. The mean interval of repeat injection was 10.2 ± 2.1 weeks. Three episodes of ocular adverse drug reaction were reported, including two patients developing subretinal hemorrhage while one having a retinal pigment epithelial (RPE) tear. Notably, no intraocular inflammation (IOI) was seen in any of the eyes, and no systemic side effects were identified. Conclusion:In a real-world scenario, brolucizumab therapy is efficacious and safe in the management of nAMD over the short term. Further long-term studies are warranted to validate these findings. Additionally, lack of ocular inflammation after 126 brolucizumab injections in our Indian data is peculiar and underlines the necessity to explore the role of race and genetics in predisposing to/safeguarding against brolucizumab-related IOIs.

Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients

“…This benefit was also maintained at weeks 44 and 48. These results corroborate previous studies [ 15 , 17 , 19 , 20 ]. The SHRM resolution was comparable for both brolucizumab and aflibercept treated eyes.…”

First Year Real Life Experience With Intravitreal Brolucizumab for Treatment of Refractory Neovascular Age-Related Macular Degeneration

“… - Monthly treatment, most of the IOIs were reported during the first 3 months of treatment ( Exchange and Koersen, 2021 ; Monés et al, 2021 ). - Finally, the absence of IOI after 126 brolucizumab IVIs in an Indian study indicates the importance of investigating the potential of race and genetics in predisposing to brolucizumab-related IOI ( Chakraborty et al, 2021 ). …”

“…- Finally, the absence of IOI after 126 brolucizumab IVIs in an Indian study indicates the importance of investigating the potential of race and genetics in predisposing to brolucizumab-related IOI ( Chakraborty et al, 2021 ).…”

Evaluation of cardiac parameters and other safety outcomes of brolucizumab treatment in patients with neovascular age‐related macular degeneration

“…[10][11][12][13] Furthermore, recent real-world evidences of brolucizumab treatment in nAMD patients did not report any new safety signals specific to CV events; however, none of them specifically investigated any ECG-related cardiac parameters. 20,21 This present study is the first to describe the effect of intravitreal anti-VEGF treatment (brolucizumab 6 mg) on multiple 12-lead…”

“…Preclinical and clinical studies have also confirmed no known systemic safety issues with brolucizumab 10–13 . Furthermore, recent real‐world evidences of brolucizumab treatment in nAMD patients did not report any new safety signals specific to CV events; however, none of them specifically investigated any ECG‐related cardiac parameters 20,21 …”