EFFICACY AND SAFETY OF AFLIBERCEPT FOR THE TREATMENT OF IDIOPATHIC CHOROIDAL NEOVASCULARIZATION IN YOUNG PATIENTS The INTUITION Study

摘要

Purpose: To evaluate the mean change in visual acuity at 52 weeks in patients with idiopathic choroidal neovascularization treated with aflibercept. Methods: We conducted a prospective noncomparative open-label Phase-II trial. The dosage regimen evaluated in this study was structured into two periods: (1) from inclusion to 20 weeks: a treat-and-extend period composed of three mandatory intravitreal injections, and complementary intravitreal injections performed if needed; (2) from 21 weeks to 52 weeks: a pro re nata period composed of intravitreal injections performed only if needed. Results: A total of 19 patients were included, and 16 completed the 52-week study. At baseline, the mean best corrected visual acuity was 66.56 (+/- 20.72) letters (approximate to 20/50 Snellen equivalent), and the mean central retinal thickness was 376.74 mu m (+/- 93.77). At 52 weeks, the mean change in the best-corrected visual acuity was +19.50 (+/- 19.36) letters 95 confidence interval = +9.18 to +29.82. None of the patients included lost >= 15 letters at 24 weeks or 52 weeks. The mean change in central retinal thickness was -96.78 mu m (+/- 104.29) at 24 weeks and -86.22 mu m (+/- 112.27) at 52 weeks. The mean number of intravitreal injections was 5.4 (+/- 3.0) at 52-weeks. No ocular serious adverse events related to the treatment were reported. Conclusion: The present analysis shows clinically significant functional and anatomical treatment effect of aflibercept in case of idiopathic choroidal neovascularization. The treat-and-extend regimen proposed after the first injection seems adequate to treat most neovessels.