Abstract
Purpose :
To evaluate visual and anatomic outcomes with intravitreal aflibercept 8 mg and 2 mg in patients with DME by baseline (BL) BCVA 20/50 or worse (<69 letters) and 20/40 or better (≥69 letters).
Methods :
PHOTON (NCT04429503) was a double-masked, 96-week, non-inferiority trial that randomly assigned patients with DME to receive aflibercept 8 mg every 12 or 16 weeks after 3 monthly doses (8q12 [n=328] or 8q16 [n=163]) or aflibercept 2 mg every 8 weeks after 5 monthly doses (2q8 [n=167]). From Week 16, dosing intervals were shortened if 8-mg patients met prespecified dose regimen modification criteria. In this post hoc analysis, mean changes from BL in BCVA and central retinal thickness (CRT) at Week 48 were evaluated by BL BCVA 20/50 or worse and 20/40 or better.
Results :
Mean BL BCVA in the 2q8, 8q12, and 8q16 groups ranged from 55.1-57.8 letters in patients with BL BCVA 20/50 or worse (n=422) and 72.6-73.2 letters in those with BL BCVA 20/40 or better (n=236). Mean CRT at BL ranged from 472.7-491.5 µm in patients with BL BCVA 20/50 or worse and 400.6-411.1 µm in those with BL BCVA 20/40 or better. At Week 48, mean change from BL in BCVA with 2q8, 8q12, and 8q16, respectively, was +10.7, +10.5, and +9.2 letters in patients with BL BCVA 20/50 or worse and +6.0, +6.0, and +5.6 letters in patients with BL BCVA 20/40 or better. Mean change from BL in CRT at Week 48 with 2q8, 8q12, and 8q16, respectively, was -195.0, -194.7, and -172.6 µm in patients with BL BCVA 20/50 or worse and -99.4, -134.1, and -107.9 µm in patients with BL BCVA 20/40 or better. In the 8q12 and 8q16 groups, respectively, 88.8% and 84.7% of patients with BL BCVA 20/50 or worse and 94.6% and 96.6% of patients with BL BCVA 20/40 or better maintained their randomized dosing intervals through Week 48.
Conclusions :
Aflibercept 8 mg demonstrated meaningful visual and anatomic improvements from BL to Week 48 in patients with DME irrespective of BL BCVA (20/50 or worse or 20/40 or better). Patients with BL BCVA 20/50 or worse achieved numerically greater visual gains and improvements in CRT than those with BL BCVA 20/40 or better. Greater proportions of 8-mg patients with BL BCVA 20/40 or better vs 20/50 or worse maintained their randomized dosing intervals through Week 48.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.