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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated at inclusion (mandatory injection) followed by mandatory injections at week 4, week 8, week 20, week 32 and week 44. During the other visits, an injection can be performed in case of CNV activity (PRN regimen).Therefore, each patient receives between 6 and 13 injections in the whole study.
Mean change in best corrected visual acuity (BCVA) from baseline to 52 weeks in patients with choroidal neovascularization in angioid streaks treated with Aflibercept
Change in BCVA number of letters gained or lost between baseline and 52 weeks. BCVA is measured on the scale Early Treatment Diabetic Retinopathy Study (ETDRS) at an initial distance of 4 meters.
Time frame: 52 weeks
Mean change in BCVA from baseline to 24 weeks
Mean change in BCVA expressed as number of letters gained or lost measured with ETDRS scale from baseline to week 24
Time frame: 24 weeks
Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 24 weeks.
percentage of the patients who lost fewer than 15 letters of BCVA measured with ETDRS scale from baseline to week 24.
Time frame: 24 weeks
Percentage of patients who lost fewer than 15 letters of BCVA from baseline to 52 weeks
Percentage of the patients who lost fewer than 15 letters of BCVA measured with ETDRS scale from baseline to week 52.
Time frame: 52 weeks
number of injections per patient for 52 weeks
Time frame: 52 weeks
Average change in central retinal thickness (CRT) between baseline and 24 weeks
Average change in central retinal thickness (CRT) in micrometers measured with Spectral domain Optical Coherence Tomography (SD-OCT) from baseline to week 24
Time frame: 24 weeks
Average change in central retinal thickness (CRT) between baseline and 52 weeks
Average change in central retinal thickness (CRT) in micrometers measured with Spectral domain Optical Coherence Tomography (SD-OCT) from baseline to week 52
Time frame: 52 weeks
Mean change in neovascular lesion size between baseline and 52 weeks.
change in neovascular lesion size measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Time frame: 52 weeks
Mean change in neovascular lesion morphology between baseline and 52 weeks.
Mean change in neovascular lesion morphology measured with fluorescein and/or indocyanine green angiography from baseline to week 52
Time frame: 52 weeks
Side-effects observed during the study
Time frame: 52 weeks
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