Choroidal Neovascularization in Angioid Streaks Clinical Trial
Official title:
Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients.
Angioid streaks are rare lesions associated to retinal pigment epithelium degenerations.
They can be caused by general diseases as pseudoxanthoma elasticum, Paget's disease or
drepanocytosis. Choroidal neovascularization (CNV) represents the most frequent complication
for those patients. It leads to a rapid and important loss of visual acuity. CNV in angioid
streaks represent the fourth leading cause of CNV in young patients.
CNV in angioid streaks is treated at the moment with off-label anti-VEGF (Vascular
Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new
anti-VEGF currently indicated in AMD. Case reports suggest that such patients would not need
as many injections as in AMD.
ASTRID is an open-label, single arm, prospective, multicenter, phase II study. The main
objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment
with aflibercept on the visual acuity of patients affected by CNV in angioid streaks. A
specific dosage regimen is designed to achieve maximum efficiency. The patients are followed
on a monthly basis until 52 weeks. Six injections are mandatory, the other ones are injected
only in case of active CNV.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment