Researchers conducted a study to assess the effectiveness and safety of aflibercept at two different dosages—8 mg and 2 mg—in patients with diabetic macular edema (DME). Diabetic macular edema is a significant cause of vision loss among patients with diabetes, and optimizing treatment options is crucial for improving visual outcomes and patient well-being.
The PHOTON trial (NCT04429503) is an ongoing, double-masked, non-inferiority study conducted over 96 weeks. Participants were randomly assigned to receive aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16) after three initial monthly doses or aflibercept 2 mg every 8 weeks (2q8) following five initial monthly doses. The primary endpoint was the mean change from baseline in BCVA at Week 48, while secondary endpoints included the proportion of patients with at a least 2-step improvement in DRSS score at Week 48 and changes in total fluorescein leakage area.
The study demonstrated that aflibercept 8 mg was non-inferior to the 2 mg dosage in terms of BCVA improvement at Week 48, with mean changes of +9.2, +8.8, and +7.9 letters for 2q8, 8q12, and 8q16, respectively. Additionally, the proportion of patients with at least a 2-step improvement in DRSS score was 27%, 29%, and 20% for the respective dosages. Most notably, 93% of patients in the combined 8 mg group maintained a dosing interval of at least 12 weeks, while 89% of those in the 8q16 group kept a 16-week interval.
Both aflibercept dosages demonstrated similar safety outcomes through Week 48, with no new safety signals observed during the trial.
The findings of the PHOTON trial highlight the efficacy and safety of aflibercept in treating diabetic macular edema. Aflibercept 8 mg exhibited comparable efficacy to the 2 mg dosage, offering an extended dosing interval of ≥12 weeks for the majority of patients. These results suggest that aflibercept 8 mg could be a promising treatment option for DME patients, providing greater therapeutic benefits and equivalent safety when compared to aflibercept 2 mg.