Session Title: Free Paper Session 9: AMD III
Session Date/Time: Friday 08/09/2017 | 08:00-09:30
Paper Time: 09:06
Venue: Room 117
First Author: : M.Ohji JAPAN
Co Author(s): : A. Okada K. Takahashi M. Kobayashi Y. Terano
The main objectives of the ALTAIR study were to evaluate the efficacy and safety of intravitreal injection of aflibercept (IVT-AFL) with two different approaches of Treat and Extend (T&E) dosing regimen in Japanese patients with age-related macular degeneration (wAMD).
ALTAIR was conducted at 40 sites in Japan. Patients aged ≥50 years with wAMD and a best-corrected visual acuity (BCVA) of 73-25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the study eye were included.
A randomized, open-label, multicentre Phase 4 study conducted in Japan. Patients received IVT-AFL 2mg at baseline and every 4 weeks until week 8, and at week 16, were randomized 1:1 to T&E group with 4 weeks adjustment (4W-Adj; length of extension of the injection interval were 4 weeks from the last interval and length of shortening of the injection interval were 2 weeks) and 2 weeks adjustment (2W-Adj; length of extension and shortening injection interval were 2 weeks from the last interval). After Week 16, the interval of IVT-AFL between two injections was not less than 8 weeks and not more than 16 weeks. The primary endpoint was the mean change in BCVA from baseline to Week 52.
246 patients were included (full analysis set). Baseline demographics were similar between groups, 72.4% were male; mean age was 74.0 years. Baseline BCVA was 55.3 vs 54.8 ETDRS letters in 4W-Adj and 2W-Adj, respectively. 4W-Adj group was non-inferior to 2W-Adj group for the primary endpoint (8.4 vs 9.0 ETDRS letters, respectively; least square difference: -0.4, CI: -3.8, 3.0). The mean change in central retinal thickness (CRT) from baseline to Week 52 in 4W-Adj and 2W-Adj were significantly decreased (-126.1 vs -134.4 um, respectively). The mean number of IVT-AFL up to Week 52 in 4W-Adj and 2W-Adj were 6.9 vs 7.2, and most frequent number of IVT-AFL were 6.0 (39.8%) vs 7.0 (54.5%), respectively. The mean last interval of IVT-AFL up to Week 52 in 4W-Adj and 2W-Adj were 11.8 vs 10.7 weeks, and the mean intended interval assessed at the last visit were 12.1 vs 12.0 weeks, respectively. The intended interval of 12 weeks or more at the last visit were achieved in 57.7% of patients in 4W-Adj and in 56.8% of patients in 2W-Adj. The incidence of treatment-emergent adverse events (TEAEs) was similar between groups (15.4% vs 11.3%). Most common ocular TEAE was conjunctival haemorrhage (5.7% vs 2.4%, respectively).
Two different interval approaches of T&E dosing regimens of IVT-AFL demonstrated significant visual acuity gains and CRT improvement. Majority of patients achieved an intended interval of 12 weeks and more at the last visit. Safety profile of IVT-AFL was consistent with previous studies.