Aim This study aims to assess the impact of continued ranibizumab treatment for neovascular age-related macular degeneration on patients from the MARINA and ANCHOR randomised clinical studies who lost ≥3 lines of best-corrected visual acuity (BCVA) at any time during the first year of treatment.
Methods Baseline characteristics, mean BCVA over time and ocular adverse events (AEs) were evaluated both for patients whose BCVA loss occurred at any post-baseline visit and for patients whose BCVA loss was acute. The visit when the ≥3-line BCVA loss was detected was defined as the new baseline.
Results Continued monthly ranibizumab treatment led to an improvement in mean BCVA from the new baseline. On average, patients with acute BCVA loss gained 11.9 letters at 3 months after the new baseline, compared with 0.3 letters gained with sham. No strong signals were detected in patient demographics and baseline characteristics for prognostic markers of BCVA loss. Furthermore, there was no pattern in the AE profile of patients with acute BCVA loss to suggest that BCVA recovery could be attributed to spontaneously resolving AEs.
Conclusion Continued ranibizumab treatment appears to be beneficial for patients with neovascular age-related macular degeneration who experience a ≥3-line BCVA loss during the first year of treatment.
- neovascular AMD
- treatment outcomes
- treatment lasers
- clinical trial
- treatment other
- treatment surgery
- treatment medical
- public health
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Funding Medical writing services were provided with funding from Novartis Pharma AG (Basel, Switzerland).
Competing interests SW is a consultant and/or lecturer for Allergan, Bayer, Molecular Partners and Novartis Pharma AG. The University of Bern performs contract research as a clinical trial centre and as a central reading centre. FH received honoraria from Alcon, Bayer, GlaxoSmithKline, Heidelberg Engineering, Novartis Pharma AG, Ophthotec and Pfizer, and grants from Heidelberg Engineering. J-FK is a consultant for Alcon, Allergan, Bayer and Novartis Pharma AG. PL is a consultant and/or lecturer for Allergan, NeoVista, Novartis Pharma AG, Optimedica and QLT, and has received patents and royalties from Iridex Co. PM received consultancy and lecture fees from Novartis Pharma AG, Pfizer, Allergan, Solvay (now Abbott) and Bayer. He has also received travel reimbursements from these companies. CP received consultancy fees and honoraria from Alcon, Bayer and Novartis Pharma AG, and grants from Novartis Pharma AG. US-E is a consultant for Alcon, Bayer, Novartis Pharma AG and Pfizer. The University of Vienna performs contract research as a clinical trial centre and as a central reading centre. AW is an employee of Novartis Pharma AG. YH is a former employee of Novartis Pharma AG and is currently an employee of Allergan.
Ethics approval This is a subanalysis of clinical trial data. Ethics committee/institutional review board approval was obtained for the original studies ANCHOR and MARINA, which have already been published.
Provenance and peer review Not commissioned; externally peer reviewed.