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About
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.
Sex
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Inclusion criteria
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:
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 retinal atrophy in the studied eye
Retinal pigment epithelial tear reaching the macula in the studied eye
Medical history of intravitreal medical device in the studied eye
Medical history of auto-immune or idiopathic uveitis
Proved diabetic retinopathy
Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments
Aphakia or lack of lens capsule (not removed by YAG laser) in the studied eye
Arterial hypertension that is not controlled by an appropriate treatment and defined by one measure of systolic blood pressure > 180mmHG or 2 consecutive measures > 160mmHg, or by a diastolic blood pressure > 100mmHg
Antecedents of cerebrovascular disease or myocardial infarction during the last 6 months before inclusion (J1)
Antecedents of any pathology, metabolic disease, or any serious suspicion of disease during the clinical or laboratory exam that would contraindicate the use of the product, could affect the interpretation of the study results or lead to major risks of complication for the subject
Renal insufficiency requiring dialysis or renal transplantation
Previous (less than a year) or actual treatment with systemic administration of anti-VEGF therapy
Known hypersensitivity to aflibercept, or another drug composite of the medicinal product used; allergy to fluorescein, indocyanine green, anaesthetic eye drops
Active or suspected ocular or peri-ocular infection
Active severe intraocular inflammation
Medical history of intra-ocular surgery within 28 days before the first injection in the studied eye
Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion
Follow up not possible during 12 months
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Data sourced from clinicaltrials.gov
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