The following is a summary of “Intravitreal Aflibercept 8 mg for DME: Week 48 Efficacy Outcomes by Baseline Demographics in the Phase 2/3 PHOTON Trial,” published in the issue of Ophthalmology 2023 issue by Adrean et al.
Researchers performed a prospective study to compare the effectiveness of aflibercept 8 mg and 2 mg in diabetic macular edema (DME) patients at 48 weeks, stratified by baseline demographics.
The study lasted 96 weeks, comparing the effectiveness and safety of aflibercept dosages. The analysis divided patients into 2 groups that were 8q12 (n = 328) and 8q16 (n = 163). They received 8 mg every 12 or 16 weeks after an initial 3 monthly doses, and 2q8 (n = 167) group received 2 mg every 8 weeks after 5 monthly doses. The trial assesses the mean change in best corrected visual acuity (BCVA) from baseline at week 48, considering factors such as sex, age, race, and ethnicity.
The study observed mean BCVA changes from baseline (letters) in different subgroups. For males, the changes at Week 48 with dosing schedules of 2q8, 8q12, and 8q16 were (n = 401):+8.7, +8.4, and +8.3 letters, respectively. For females (n = 257), the changes were +9.8, +9.6, and +7.2 letters. In the age groups, those under 55 years(n = 144) had changes of +13.0, +10.2, and +11.1 letters, while those aged 55 to <65 years(n = 225) had changes of +10.3, +8.0, and +7.1 letters. Those aged ≥65 to <75 years (n = 218) had changes of +6.9, +9.2, and +7.0 letters. Results were similar for White and Asian populations (White [n = 471]: +9.3, +9.5, +8.3; Asian [n = 101]: +7.3, +5.9, +6.6), and ethnicity (Hispanic or Latino [n = 119]: +8.9, +8.3, +7.6; non-Hispanic or Latino [n = 525]: +9.4, +8.8, +7.9). Specific subgroups (≥75 years and Black) were not evaluated due to small sample sizes.
The study found that aflibercept 8 mg improved vision in all patient groups studied.