Aflibercept 8 mg improves vision in DME, with similar outcomes by age, sex, race
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INDIANAPOLIS — Intravitreal aflibercept 8 mg achieved improvements in best corrected visual acuity among a diverse cohort of patients with diabetic macular edema, according to data presented at Academy 2024.
“The 8 mg demonstrated meaningful BCVA gains from baseline regardless of age, gender, race, ethnicity, acuity or central retinal thickness,” Raman Bhakhri, OD, FAAO, associate professor at Illinois College of Optometry, told attendees.
To determine whether aflibercept 8 mg and 2 mg could achieve similar visual improvements in a demographically diverse group of patients with DME, Bhakhri and colleagues conducted the double-masked, non-inferiority PHOTON trial.
They randomly assigned patients to aflibercept 8 mg every 12 weeks (n = 328) or 8 mg every 16 weeks (n = 163) after three initial monthly doses, or aflibercept 2 mg every 8 weeks (n = 167) after five initial monthly doses.
The primary outcome was change in BCVA from baseline to week 96, with assessments conducted by participant sex, age, race and ethnicity, as well as baseline BCVA and central retinal thickness.
At week 96, the mean BCVA change among men was + 8.2 in the 2 mg group, + 8.2 letters in the 8 mg every 12 weeks group and + 8.5 letters 8 mg every 16 weeks group, with changes of + 8.7, + 9.8 and + 5.9 letters, respectively, among women.
By age, patients younger than 55 years had changes of + 10.8, + 10.7 and + 9.6 letters, respectively, while participants aged 55 to 64 years had changes of + 7.1, + 8.1 and + 8.6. Those aged 65 to 74 years had mean changes of + 8.4, + 8.8 and + 6 letters.
The researchers reported similar results by race and ethnicity, as well as by baseline BCVA and central retinal thickness, with no “clinically meaningful” differences across subgroups.
Bhakhri noted, however, that participants with worse baseline BCVA had greater gains vs. those with better baseline BCVA.
“They had more letters to gain is the way I think of it,” he said.
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Bhakhri R, et al. Intravitreal aflibercept 8 mg for diabetic macular edema: Week 96 efficacy outcomes by baseline characteristics in the phase 2/3 PHOTON trial. Presented at: Academy 2024; Nov. 6-9; Indianapolis.
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