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

Abstract

Background The current standard treatment for neovascular age-related macular degeneration (nAMD) involves intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents. The aim of the present study was to compare the effectiveness and safety of two anti-VEGF drugs: brolucizumab and aflibercept, in treatment-naïve nAMD Indian patients over a period of 48 weeks. Methods A prospective, randomized, single-centre, single-blinded, two-arm comparative study was conducted between March 2021 and February 2022. Of the 114 patients, 56 received intravitreal injections of brolucizumab (6 mg/50 µL) while 58 received aflibercept (2 mg/50 µL). The patients received 03 initial loading doses at 4-week intervals of both the agents and then respective therapies were given as individualized pro re nata (PRN) regimen based on the signs of active macular neovascularization. The functional and anatomical outcomes measured were mean change in best-corrected visual acuity (BCVA, logMAR), central macular thickness (CMT, µm), presence of intraretinal fluid, subretinal fluid or subretinal hyper-reflective material. Furthermore, the average number of additional injections required after the loading doses, the injection-free interval and safety of both the drugs were also assessed. Results Brolucizumab was found to be non-inferior to aflibercept in terms of mean change in BCVA (−0.13 ± 0.21 logMAR vs. −0.10 ± 0.15 logMAR) and reduction in CMT (−112.59 ± 81.23 µm vs. −86.38 ± 71.82 µm). The percentage of eyes with IRF and SHRM was comparable between both the groups while fewer eyes treated with brolucizumab indicated SRF presence than aflibercept after the loading doses. These beneficial effects of brolucizumab were observed with significant (p < 0.0001) lesser number of injections (1.8 ± 1.1 vs. 3.8 ± 1.5) from week 12 to week 48. Moreover, the probability of no injections after the loading doses was significantly higher with brolucizumab compared to aflibercept indicating prolonged injection-free intervals. The average ocular side effects were comparable in the two groups. One adverse event of severe vitritis requiring treatment with oral steroids occurred in Brolucizumab group, while no such event occurred in Aflibercept group. Conclusion The results of the present study suggest non-inferiority of brolucizumab PRN regimen to aflibercept PRN regimen in treatment naïve nAMD Indian patients while achieving longer inter-injection intervals. Trial registration Clinical Trial Registration of India (CTRI/2021/06/034415). Registered 03 March, 2021, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54328&EncHid=&userName =

Short-term Efficacy and Safety of Intravitreal Brolucizumab Injection for Treatment-Naive Exudate Age-related Macular Degeneration: A Multicenter Study

“…This retrospective study compared clinical efficacy and adverse event following intravitreal brolucizumab injection compared to aflibercept in treatment-naive nAMD patients during loading-phase treatment. In previous studies, brolucizumab resulted in similar BCVA improvement and CMT reduction but greater central choroidal thickness reduction than af libercept [14,15,18]. In the present study, BCVA was significantly improved and CMT was significantly decreased in both groups.…”

Prevalence and Associated Risk Factors of Age-Related Macular Degeneration in the Retina Clinic at a Tertiary Center in Makkah Province, Saudi Arabia: A Retrospective Record Review

“…Similarly, a Spanish study found that dry AMD is more prevalent than wet AMD [9]. However, the prevalence of wet AMD is twice as high as that of dry AMD in some other studies [15,16].…”

Functional and anatomical outcomes of brolucizumab for nAMD in a real-life setting

“…This is in accordance with previous literature. Mishra et al demonstrated that both IRF and SRF were detected in 82.1% of patients at baseline; after the loading phase, they reduced respectively to 41.1% and 16.1% 22 . Toto et al 18 showed a reduction in IRF and subfoveal-SRF rates in type 1 MNV between baseline and week 12, respectively changing from 41.7 to 20.8% and from 62.5 to 4.2%.…”