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Abstract
Objective To evaluate 12-month outcomes in treatment-naïve patients with neovascular (wet) age-related macular degeneration (AMD) stratified by intravitreal aflibercept (IVT-AFL) regimen.
Methods and analysis Patients included in the 12-month interim analysis of Real life of intravitreal Aflibercept In FraNce: oBservatiOnal Study in Wet AMD (RAINBOW), a 4-year, ongoing observational study conducted in France, were stratified by IVT-AFL dosing regimen. Safety (n=593) and effectiveness (n=428) data were analysed. Regimens included a regular cohort (three initial monthly IVT-AFL injections and ≥6 injections) and irregular cohorts (<6 injections) with and without three initial monthly injections. The main outcome measure was mean gain in best-corrected visual acuity (BCVA) at 12 months.
Results Mean number of IVT-AFL injections was 6.0 (all patients, n=513), 7.2 (regular cohort, n=102), 6.1 (irregular cohort with three initial monthly injections, n=266) and 5.2 (irregular cohort without three initial monthly injections, n=60). Overall mean gain in BCVA at 12 months was 5 letters; +7.1 letters (regular cohort) and +5.6 letters (irregular cohort with three initial monthly injections), both p<0.001 versus baseline, and –1.1 letters (irregular cohort without three initial monthly injections), p=0.669. Improvements in BCVA were also significantly greater in the regular cohort (p<0.001) and irregular cohort with three initial monthly injections (p=0.003) compared with the irregular cohort without three initial monthly injections. Ocular and non-ocular adverse events were reported in 14.7% and 17.4% of all patients, respectively.
Conclusion Treatment-naïve patients with neovascular AMD receiving three initial monthly injections followed by regular or irregular injections over 12 months experienced better visual acuity outcomes than those receiving irregular treatment without three initial monthly injections.
Trial registration number NCT02279537.
- treatment medical
- drugs
- vision
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Footnotes
Presented at Annual Meeting of the Association for Research in Vision and Ophthalmology, Seattle, Washington, USA, 1–5 May 2016; 16th European Society of Retina Specialists Congress, Copenhagen, Denmark, 8–11 September 2016; 2017 MaculArt Meeting: Imaging and Managing Macular Diseases, Paris, France, 2–4 July 2017; 123rd Congrès de la Société Française d’Ophtalmologie, France, Paris, 5–9 May 2017; 49th Annual Scientific Congress of the Royal Australian and New Zealand College of Ophthalmologists, Perth, WA, Australia, 28 October–1 November 2017; 9th Annual Congress on Controversies in Ophthalmology: Europe, Athens, Greece, 22–24 March 2018; 124th Congrès de la Société Française d’Ophtalmologie, Paris, France, 5–8 May 2018.
Contributors MW, LK, FC, CF, IA, ID and SYC contributed to the design; data acquisition, analysis and interpretation; and preparation and final review of the manuscript.
Funding The RAINBOW study was sponsored by Bayer HealthCare SAS. The sponsor participated in the design and conduct of the study, analysis of the data and preparation of the manuscript. Medical writing assistance was provided by Nathan Ley, PhD, of PAREXEL and Louise Brady, PhD, of Apothecom, and was funded by Bayer HealthCare SAS.
Competing interests MW: Alcon, Alimera, Allergan, Bayer, Novartis, Thea. LK: AbbVie, Allergan, Bayer, Novartis, Roche, Thea. FC: Allergan, Bayer, Novartis, Roche. CF: Allergan, Bayer, Novartis; IA: Bayer, Novartis. ID: employee of Bayer. SYC: Allergan, Bayer, Novartis, Thea, Tilak.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval No independent ethics committee and institutional review board approval was obtained as this is not required in France for observational studies. However, the RAINBOW study protocol was reviewed and approved by a French data privacy committee (Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé, and Commission Nationale de l’Informatique et des Libertés).
Provenance and peer review Not commissioned; externally peer reviewed.
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