DRKS00027302招募中1 期
Intravitreal Panitumumab for Prevention of Myopic Axial Elongation in Highly Myopic Adult Eyes with Myopic Macular Degeneration - Panitumumab for High Myopia
fa Eye Research Institute0 个研究点目标入组 40 人开始时间: 2021年12月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 120 Years（—）
- 性别
- All
入选标准
- •Age of 40+ years,
- •- Axial length =26.5mm;
- •- Myopic macular degeneration (category 3 (patchy atrophy) or higher).
- •- Clear optic media to allow imaging of the macula and optic nerve head;
- •- Progression of myopic maculopathy (increase in diffuse chorioretinal atrophy, enlargement of patchy atrophies, increase in the category of myopic macular degeneration, enlargement in parapapillary gamma/delta zone, increase in axial length, increase in myopic refractive error (after exclusion of lentogenic myopization), or myopia-associated reduction in best corrected visual acuity
排除标准
- •- Previous vitreoretinal or retinal surgeries (except for peripheral retinal laser coagulation)
- •- Previous intravitreal medical therapy with vascular endothelial growth factor (VEGF) inhibitors within the last three months before inclusion into the study;
- •- Active subretinal choroidal neovascularization;
- •- Subretinal or intraretinal edema in the macula;
- •- Pregnancy;
- •- Lack of reliable contraception unless menopause has occurred;
- •- Known intolerance or hypersensitivity against panitumumab (Vectibix®) or its ingredients;
- •- Participation in another clinical trial (parallel or within a cooling off period of a previous trial;
- •- Missing possibility to understand and sign a written informed consent;
研究者
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