WithdrawnPhase 2

Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Choroidal Neovascularization in Angioid Streaks in Young Patients (ASTRID).

0Started 2016-02

Plain-language summary

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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 \< Age \< 50 years old * Patient who give voluntary signed informed consent * Patient affiliated with the French universal health care system or similar * Patient with CNV in angioid streaks, whatever caused the angioid streaks, with active primary subfoveal, retrofoveal or juxtafoveal lesions that affect the fovea as evidenced by angiography (fluorescein and/or indocyanine green) and/or SD-OCT in the studied eye * Patient willing, committed and able to return for all clinic visits and complete all study-related procedures Exclusion Criteria: * Pregnant women * Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study * Patient who is protected adults according to the terms of the law (French public health laws) * Involvement in another clinical trial (studied eye and/or the other eye) * Patient with non-angioid streaks CNV, especially: * AMD * High myopia defined as refraction ≥ - 6 diopters * Other curative treatment of CNV in angioid streaks in the studied eye during the last 3 months before the first intravitreal injection: anti-VEGF therapy, juxta- or extra-foveal macular laser, photodynamic therapy, surgery, external radiotherapy, transpupillary thermotherapy ... * Medical history of retrofoveal focal macular laser photocoagulation in the studied eye * Subretinal hemorrhage reaching the fovea center or with a size \> 50% of the lesion area * Fibrosis or retrofoveal retina…

What they're measuring

Mean change in best corrected visual acuity (BCVA) from baseline to 52 weeks in patients with choroidal neovascularization in angioid streaks treated with Aflibercept

Timeframe: 52 weeks

Trial details

NCT IDNCT02573038

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05