Abstract
Purpose :
To evaluate treatment outcomes of intravitreal aflibercept 8 mg versus 2 mg at Week 48 in patients by prior diabetic macular edema (DME) treatment status.
Methods :
PHOTON (NCT04429503), a double-masked, 96-week, non-inferiority trial, randomized patients with DME to aflibercept 8 mg q12 or q16 weeks after 3 monthly doses (8q12 [n=328] or 8q16 [n=163]) or aflibercept 2 mg q8 weeks after 5 monthly doses (2q8; n=167). From Week 16, dosing intervals were shortened if aflibercept 8 mg-treated patients met prespecified dose regimen modification criteria. Visual and anatomic outcomes were evaluated through Week 48 in patients with (n=288) and without (n=370) prior DME treatment.
Results :
Baseline best-corrected visual acuity (BCVA) was lower in the 8q16 group versus the 2q8 and 8q12 groups among patients with prior treatment (58.6 versus 62.1 and 62.3 letters, respectively) but was generally comparable across treatment groups without prior treatment. Baseline central retinal thickness (CRT) was generally similar across treatment groups with or without prior treatment. Mean BCVA change from baseline at Week 48 with 2q8, 8q12, and 8q16, respectively, was +7.4, +8.2, and +5.6 letters in patients with prior treatment and +10.7, +9.2, and +9.7 letters in patients without prior treatment. At Week 48, the corresponding proportion of patients with ≥2-step improvement from baseline in Diabetic Retinopathy Severity Scale (DRSS) score was 24%, 22%, and 17% in patients with prior treatment and 29%, 35%, and 22% in patients without prior treatment. Mean change from baseline in CRT at Week 48 with 2q8, 8q12, and 8q16, respectively, was -151.2, -168.4, and -151.6 µm in patients with prior treatment and -177.3, -174.3, and -145.6 µm in patients without prior treatment. Through Week 48, 91% and 94% of 8-mg patients with and without prior treatment, respectively, maintained ≥12-week dosing.
Conclusions :
Outcomes were generally comparable across treatment groups within subgroups of patients with or without prior treatment. BCVA gains and proportions of patients with ≥2-step improvement in DRSS at Week 48 trended numerically lower across all treatment groups in patients with versus without prior DME treatment. Similar proportions of 8-mg patients maintained ≥12-week dosing through Week 48 irrespective of prior DME treatment status.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.