Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial

Abstract

Purpose: To evaluate efficacy and safety of intravitreal injections of aflibercept (IVT-AFL) treat-and-extend (T&E) dosing regimens in treatment-naïve patients with exudative age-related macular degeneration (AMD).

Methods: Adults aged at least 50 years old with exudative AMD and best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters were included. Patients received three monthly doses of IVT-AFL 2 mg. At week 16, patients were randomized 1:1 to IVT-AFL T&E with either 2- or 4-week adjustments. The primary endpoint was mean change in BCVA from baseline to week 52. Outcomes were assessed at weeks 52 and 96.

Results: Baseline characteristics were comparable between the groups (n = 123 each). Over 52 weeks, mean number of injections was 7.2 and 6.9 and mean last injection interval was 10.7 and 11.8 weeks, for the 2- and 4-week groups, respectively. From baseline, mean change in BCVA was + 9.0 and + 8.4 letters (week 52) and + 7.6 and + 6.1 letters (week 96); mean change in central retinal thickness was - 134.4 µm and - 126.1 µm (week 52) and - 130.5 µm and - 125.3 µm (week 96). Last injection interval before week 52 was at least 12 weeks in 42.3% and 49.6% of patients and 56.9% and 60.2% before week 96. Over 96 weeks, mean number of injections was 10.4 (both groups). The safety profile of IVT-AFL was consistent with previous reports.

Conclusions: IVT-AFL administered using two different T&E regimens for treatment-naïve exudative AMD improved functional and anatomic outcomes at week 52 and outcomes were maintained to week 96. Outcomes were similar between the 2- and 4-week groups.

Trial registration: ClinicalTrials.gov identifier, NCT02305238.

Keywords: Aflibercept; Anti-vascular endothelial growth factor agents; Exudative age-related macular degeneration; Ophthalmology; Treat-and-extend.

Fig. 1

Patient disposition. *A total of eight patients were not randomized because of withdrawal by patient (n = 3), protocol violation (n = 2), physician decision (n = 1), logistic difficulties (n = 1), or no IVT-AFL injection (n = 1). 2W/4W 2-/4-week adjustment, AE adverse event, IVT-AFL intravitreal aflibercept

Fig. 2

The last injection interval up to a Week 52 and b Week 96 (FAS)

Fig. 3

Mean change in BCVA (ETDRS letter score) in IVT-AFL-2W and IVT-AFL-4W groups from baseline to week 96 (FAS). Last observation carried forward analysis. 2W/4W 2-/4-week adjustment, BCVA best-corrected visual acuity, CI confidence interval, ETDRS Early Treatment Diabetic Retinopathy Study, FAS full analysis set, IVT-AFL intravitreal aflibercept, LSM least squares mean

Fig. 4

Mean change in central retinal thickness (µm) from baseline to week 96 (FAS). Last observation carried forward analysis. 2W/4W 2-/4-week adjustment, CI confidence interval, CRT central retinal thickness, IVT-AFL intravitreal aflibercept, LSM least squares mean