Abstract
Purpose :
To evaluate baseline clinical characteristics of patients with diabetic macular edema (DME) who received intravitreal aflibercept 8 mg and maintained their randomized dosing intervals versus those whose intervals were shortened after meeting prespecified criteria through Week 48.
Methods :
PHOTON is an ongoing, double-masked, 96-week, non-inferiority trial that randomized 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]). Beginning at Week 16, dosing intervals were shortened to a minimum of 8 weeks if aflibercept 8 mg-treated patients met prespecified dose regimen modification (DRM) criteria denoting disease activity.
Results :
At baseline, best-corrected visual acuity (BCVA), central retinal thickness (CRT), and Diabetic Retinopathy Severity Scale (DRSS) scores were generally balanced across all 3 treatment groups in the overall population. Of patients completing the Week 48 visit, 273/300 (91.0%) in the 8q12 group and 139/156 (89.1%) in the 8q16 group maintained their randomized dosing intervals. In the 8q12 and 8q16 groups, 27/300 (9.0%) and 17/156 (10.9%) patients, respectively, met DRM criteria and had their dosing intervals shortened. Mean (SD) baseline BCVA in eyes with maintained vs shortened dosing intervals was 63.9 (10.1) vs 59.4 (10.0) letters in the 8q12 group and 62.7 (11.2) vs 53.7 (12.8) letters in the 8q16 group. Mean (SD) central retinal thickness (CRT) at baseline (maintained vs shortened dosing intervals) was 444.9 (129.8) vs 511.4 (117.5) µm in the 8q12 group and 447.1 (112.5) vs 534.8 (134.3) µm in the 8q16 group. Baseline DRSS score (maintained vs shortened dosing intervals) was 47 or worse in 33.7% vs 40.7% of patients in the 8q12 group and 26.6% vs 41.2% of patients in the 8q16 group. No clinically meaningful differences were observed based on age, BMI, or HbA1c at baseline.
Conclusions :
The vast majority of patients with DME who received aflibercept 8 mg maintained 12- or 16-week dosing. Patients who did not maintain their randomized dosing intervals appeared to have more severe disease at baseline than patients who maintained their randomized dosing intervals, and this trend was more pronounced in the 8q16 group.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.