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.

Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema in Routine Clinical Practice: Results from the 24-Month AURIGA Observational Study

“…The safety profile of IVT-AFL was consistent with previous studies [ 13 , 25 – 27 ]. There was one case each of uveitis and endophthalmitis that were considered both serious and treatment-related.…”

“…The functional and anatomic improvements achieved in patients with DME in AURIGA were similar to or greater than the gains observed in other prospective real-world studies of IVT-AFL. In the APOLLON study conducted in France, treatment-naïve and previously treated patients gained +6.5 letters overall between baseline and month 12 following 7.6 IVT-AFL injections ( n = 147) [ 24 ]; this decreased to +3.9 letters by month 24 after a mean total of 11.6 injections ( n = 168) [ 25 ]. From baseline to month 12, the reduction in CRT in APOLLON ranged from 130 to 138 µm across the two treatment cohorts.…”

Real-World Outcomes of Intravitreal Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema in Türkiye: MARMASIA Study Group Report No. 1

“… 45 , 46 , 47 , 48 Numerous prospective and retrospective RWE studies involving these patients have provided complementary information about the effectiveness of intravitreal anti-VEGF agents on DME, particularly emphasizing the importance of number of follow-ups and injections to avoid undertreatment. 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 …”

“… 20 , 50 Recently, the 2-year prospective APOLLON study from France reported a higher mean cumulative number of IVA injections (7.6 and 11.6) in 12 and 24 months, leading to +6.5 and +3.9 mean letter gains, respectively. 51 , 52 The authors attributed the relatively smaller visual improvements despite a higher number of IVIs at 2 years in the APOLLON study to structural changes related to the long-standing DME in previously treated patients. 52 One-year results of the global LUMINOUS study, which prospectively evaluated the effectiveness of IVR for any indications in real-life settings, showed that BCVA change from baseline in DME patients differs between -0.3 to +6.9 letters with mean numbers of IVR injections ranging from 2.2 to 6.0 among countries.…”

Management of diabetic macular oedema in France from 2012 to 2018: The nationwide LANDSCAPE study

“…In subsequent years, the number of ophthalmological consultations declined to a median of around five per year. Smaller real‐world studies of anti‐VEGF and dexamethasone implant use in DME have also shown declining frequency of ophthalmological care within the first year (Best et al., 2018; Bhandari et al., 2020; Egan et al., 2017; Epstein & Amren, 2018; Farinha et al., 2019; Hodzic‐Hadzibegovic et al., 2018; Hrarat et al., 2016; Maggio et al., 2018; Massin et al., 2019; Mitchell et al., 2020; Stefanickova et al., 2018) and up to 4 years after treatment initiation (Epstein & Amren, 2018; Korobelnik et al., 2022; Maggio et al., 2018; Malcles et al., 2017).…”