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:...
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| Format: | Article |
| Language: | English |
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BMC
2022-07-01
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| Series: | International Journal of Retina and Vitreous |
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| Online Access: | https://doi.org/10.1186/s40942-022-00401-4 |
| _version_ | 1811222947069689856 |
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| author | Sanjay Kumar Mishra Pradeep Kumar Srishti Khullar Amrita Joshi Alok Sati Sonali Vinay Kumar Deepesh Unni Atul Kumar |
| author_facet | Sanjay Kumar Mishra Pradeep Kumar Srishti Khullar Amrita Joshi Alok Sati Sonali Vinay Kumar Deepesh Unni Atul Kumar |
| author_sort | Sanjay Kumar Mishra |
| collection | DOAJ |
| description | 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 = |
| first_indexed | 2024-04-12T08:24:49Z |
| format | Article |
| id | doaj.art-cb4170324e2a4ee7898c4de07d3f811c |
| institution | Directory Open Access Journal |
| issn | 2056-9920 |
| language | English |
| last_indexed | 2024-04-12T08:24:49Z |
| publishDate | 2022-07-01 |
| publisher | BMC |
| record_format | Article |
| series | International Journal of Retina and Vitreous |
| spelling | doaj.art-cb4170324e2a4ee7898c4de07d3f811c2022-12-22T03:40:27ZengBMCInternational Journal of Retina and Vitreous2056-99202022-07-018111410.1186/s40942-022-00401-4Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patientsSanjay Kumar Mishra0Pradeep Kumar1Srishti Khullar2Amrita Joshi3Alok Sati4Sonali Vinay Kumar5Deepesh Unni6Atul Kumar7Department of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralDepartment of Ophthalmology, Army Hospital Research ReferralAbstract 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 = https://doi.org/10.1186/s40942-022-00401-4Neovascular age-related macular degenerationnAMDBrolucizumabAfliberceptVEGFIndian |
| spellingShingle | Sanjay Kumar Mishra Pradeep Kumar Srishti Khullar Amrita Joshi Alok Sati Sonali Vinay Kumar Deepesh Unni Atul Kumar Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients International Journal of Retina and Vitreous Neovascular age-related macular degeneration nAMD Brolucizumab Aflibercept VEGF Indian |
| title | Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients |
| title_full | Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients |
| title_fullStr | Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients |
| title_full_unstemmed | Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients |
| title_short | Efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age-related macular degeneration: a randomized trial in Indian patients |
| title_sort | efficacy and safety of brolucizumab versus aflibercept in patients with neovascular age related macular degeneration a randomized trial in indian patients |
| topic | Neovascular age-related macular degeneration nAMD Brolucizumab Aflibercept VEGF Indian |
| url | https://doi.org/10.1186/s40942-022-00401-4 |
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