Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema

Abstract

APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains.Trial registration number: NCT02924311.

Conflict of interest statement

JFK has received consulting fees from AbbVie Allergan, Bayer, Carl Zeiss Meditec, Janssen, Kanghong, NanoRetina, Novartis, Novo Nordisk, Roche, and Théa. VD has received consulting fees from Bayer, Novartis, Théa, and Horus Pharma. CF has received consulting fees from Allergan, Bayer, and Novartis. RT has received grants and consulting fees from AbbVie Allergan, Bayer, and Novartis; has received consulting fees from Alcon, Apellis, Genentech, KHB, Iveric Bio, Oculis, Roche, and Théa; and his department has received non-financial support from Zeiss. AGA has received consulting fees from Allergan, Bayer, Novartis, and Optos. CD has received consulting fees from AbbVie, Bayer, Horus Pharma, and Novartis. LK has received consulting fees from AbbVie Allergan, Alcon, Bayer, Krystal Biotech, Novartis, Regeneron, and Théa. PM has received consulting fees from Allergan, Bayer, Horus Pharma, Merck Sharp & Dohme, Novartis, and Sanofi.

© 2022. The Author(s).

Figures

Figure 1

Patient disposition. BCVA, best-corrected visual acuity; CRT, central retinal thickness; FAS, full analysis set; IVT-AFL, intravitreal aflibercept; SAS, safety analysis set. aPatients could have been excluded from the FAS for more than one reason. bPatients had follow-up data available to at least 23 months, with a visit, injection, BCVA assessment, or optical coherence tomography evaluation between 23 and 25 months from the first IVT-AFL injection.

Figure 2

Change in visual acuity for all patients in the FAS with a BCVA assessment at baseline and Month 24, stratified according to treatment cohort. Values above each bar indicate the mean (± standard deviation) change in BCVA letter score from baseline to Month 24. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; FAS, full analysis set. ***p < 0.001 and **p < 0.01 for mean change at Month 24 versus baseline (Student t-test).

Figure 3

Mean CRT change over 24 months according to treatment cohort. Data are for all patients in the FAS with a CRT assessment at Month 24; error bars denote standard deviation. CRT, central retinal thickness; FAS, full analysis set.

Figure 4

Number of injections received over 24 months according to baseline BCVA and treatment cohort in the overall FAS. Data are for all patients in the FAS with follow-up data on treatment exposure available to at least 23 months (i.e., with an injection between 23 and 25 months from the first IVT-AFL treatment). BCVA, best-corrected visual acuity; FAS, full analysis set; IVT-AFL, intravitreal aflibercept.