NL-OMON33994已完成3 期
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
Oogziekenhuis Rotterdam0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- informed consent
- •- age >= 65 years
- •- AMD in combination with either of the following conditions:
- •1 visual loss of >= 15 letters on the ETDRS chart after 3 anti-VEGF injections,
- •2 subfoveal RPE-tear,
- •3 massive submacular haemorrhage.
- •- visual acuity of 20/63 to 20/800.
- •- recent (< 3 months) activity of the lesion
- •- myopia < -8 D
- •- clear media to permit fundus photography, FAG, ICG-A and OCT
- •- capable to follow instructions
- •- anticoagulant drugs can be discontinued during 6 weeks
排除标准
- •- haemorrhage or PED secondary to:
- •1 retinal angiomatous proliferation,
- •2 aneurysm,
- •3 CNV associated with high myopia,
- •4 polypoidal choriodopathy.
- •- 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.
- •- serious allergy to fluorescein or indocyanine green dye
- •- significant other ocular disorders affecting visual acuity
- •- immunocompromised
- •- current treatment for active systemic infection
研究者
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