Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial. - Anti-VEGF versus RPE-choroid graft

Rotterdam Eye Hospital0 个研究点目标入组 20 人开始时间: 2008年12月11日最近更新: 2022年4月19日

研究概览

暂无简介。

•- informed consent
•- age = 65 years
•- AMD in combination with either of the following conditions:
•- visual loss of = 15 letters on the ETDRS chart after 3 anti-VEGF injections,
•- subfoveal RPE-tear,
•- massive submacular haemorrhage (i.e. extending beyond the vascular arcades, subfoveal thickness of 1.5 mm (ultrasonography), and no subfoveal red blood.
•- visual acuity of 20/63 to 20/800.
•- history or examination must indicate recent (< 3 months) activity of the lesion
•(i.e. recent haemorrhage, change of lesion compared to previous examination, deterioration of VA, scotoma or metamorphopsia)
•- myopia < -8 D
•- clear media to permit fundus photography, FAG, ICG-A and OCT
•- capable to follow instructions
•- willing and physically able to complete study visits during at least 12 months
•- anticoagulant drugs (Coumarin, antiplatelet agents) can be discontinued during 6 weeks
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- haemorrhage or PED secondary to:
•- retinal angiomatous proliferation
•- aneurysm
•- CNV associated with high myopia
•- polypoidal choriodopathy
•- known hypersensitivity to humanized monoclonal antibodies
•- current acute ocular or peri-ocular infection
•- any major surgical procedure (scheduled) within 1 month of study entry not related to this study, cataract surgery excepted.
•- known serious allergy to fluorescein or indocyanine green dye
•- significant other ocular disorders affecting visual acuity
•- immunocompromised
•- current treatment for active systemic infection

发起方

Rotterdam Eye Hospital