Intravitreal Aflibercept for Choroidal Neovascularization Secondary to Angioid Streaks (EYLEA-STRIE) - EYLEA-STRIE

IRCCS Ospedale San Raffaele U.O. Oculistica0 个研究点开始时间: 2014年5月20日最近更新: 2015年8月17日

试验速览

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•Men and women = 18 years of age
•Presence of CNV associated with angioid streaks, naïve or previously treated with exudative manifestations involving the fovea
•Best-corrected visual acuity (BCVA) between 20/400 and 20/25.
•Signed Informed Consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Prior antiangiogenic treatment within 30 days prior the Screening
•Hypersensitivity to the active substance or to any of the excipients
•ocular or periocular infection suspected or in progress
•severe intraocular inflammation in progress
•Inability to document the lesion with retinography, retinal fluorescein angiography (FAG), autofluorescence, optical coherence tomography (OCT) for media opacities, allergy to dyes, lack of venous access.
•Any other medical condition of the eye that can irreversibly affect the visual acuity in the study eye, including amblyopia, ischemic optic neuropathy, clinically significant diabetic macular edema, severe nonproliferative diabetic retinopathy
•Women who are pregnant or breastfeeding. Women of childbearing age will be excluded unless they make use of contraceptive during treatment and for at least 3 months after the last injection of intravitreal Aflibercept

发起方

IRCCS Ospedale San Raffaele U.O. Oculistica