Background/Aims To compare the efficacy of ranibizumab (0.5 mg) with aflibercept (2 mg) in the treatment of cystoid macular oedema due to branch retinal vein occlusion (BRVO) over 12 months.
Methods A multicentre, international, database observational study recruited 322 eyes initiating therapy in real-world practice over 5 years. The main outcome measure was mean change in EDTRS letter scores of visual acuity (VA). Secondary outcomes included anatomic outcomes, percentage of eyes with VA >6/12 (70 letters), number of injections and visits, time to first inactivity, switching or non-completion.
Results Generalised mixed effect models demonstrated that mean (95% CI) adjusted 12-month VA changes for ranibizumab and aflibercept were similar (+10.8 (8.2 to 13.4) vs +10.9 (8.3 to 13.5) letters, respectively, p=0.59). The mean adjusted change in central subfield thickness (CST) was greater for aflibercept than ranibizumab (−170 (−153 to –187) µm vs −147 (−130 to –164) µm, respectively, p=0.001). The overall median (Q1, Q3) of 7 (4, 8) injections and 9 (7, 11) visits was similar between treatment groups. First grading of inactivity occurred sooner with aflibercept (p=0.01). Switching was more common from ranibizumab (37 eyes, 23%) than from aflibercept (17 eyes, 11%; p=0.002).
Conclusion Visual outcomes at 12 months in this direct comparison of ranibizumab and aflibercept for BRVO in real-world practice were generally good and similar for the 2 drugs, despite a greater effect of aflibercept on CST and time to first grading of inactivity.
- treatment medical
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Contributors MG and DB are inventors of the software used to collect the data for this analysis, initiated the collaborative project and revised the paper. HM implemented the trial in the UK designed and revised the paper. VN monitored data collection for the whole trial. ARH implemented the trial in Australia and with VN drafted and revised the statistical analysis plan, cleaned and analysed the data and ARH drafted and revised the paper. ARH is guarantor. CPC-G and MG implemented the trial in France and revised the paper. P-HG and SF-B revised the paper. SA, RPCM and JZ-V implemented the trial in Spain and revised the paper. JA and ILMcA revised the paper. LO'T implemented the trial in Ireland and revised the paper.
Funding This work was supported by a grant from the Royal Australian NZ College of Ophthalmologists Eye Foundation (2007-2009) and a grant from the National Health and Medical Research Council, Australia (NHMRC 2010-1012).
Competing interests MCG and DB are inventors of the software used to collect the data for this analysis. JA, ILMcA and MCG are members of advisory boards for Novartis and Bayer. JA and MCG are also members of advisory boards for Allergan. MCG and JA report personal fees and others from Novartis, others from Bayer, outside the submitted work. DB received a research grant from Novartis.
Patient consent for publication Not required.
Ethics approval Local ethics and data protection approval was obtained from the Royal Australian NZ College of Ophthalmologists and the University of Sydney Human Research Ethics Committees (HREC#16.09), the Caldicott Guardian (Dr Kilian Hynes) of the Royal Free London NHS Foundation Trust (valid until 3 September 2024), Institutional Review Boards of the Mater Private Hospital (IRB, 1/378/2130) in Dublin, Ireland; the Hospital Clinic of Barcelona, Spain (2015/57-OFT-HUSC) and the Société Française d’Ophtalmologie (2017_CLER-IRB_ll-05) in Paris, France. The study adhered to the tenets of the Declaration of Helsinki. All patients gave their informed consent. This consisted of opt-in consent from patients in France, Ireland, Spain and the UK, while the ethics committee in Australia approved the use of opt-out patient consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are not publicly available. The statistical analysis plan can be obtained by request.
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