DRKS00007761已完成未知
High myopia: extended and longterm observation of pathologic myopia patients with the risk for developing a myopic CNV. - HELP
ovartis Pharma GmbH0 个研究点目标入组 152 人开始时间: 2015年2月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 152
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Male or female Caucasian patients = 18 years of age
- •-Diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using the following criteria:
- •Ocular ultrasonography or biometry demonstrating anterior-posterior elongation measurement = 26 mm
- •abnormal change in retinal tissue by SD-OCT that are attributed to be caused by high myopia as shown in Table 4-2 in the investigator’s discretion confirmed by the reading centre.
- •-BCVA = 0.05 decimal equivalent in the study eye
排除标准
- •-Use of any investigational drugs -excluding vitamins and minerals- at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer
- •-Patients with Diabetes mellitus of any grade
- •-Patients showing signs of AMD, e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exsudative areas) in either eye
- •-Acute neovascularization (CNV or iris neovascularization) and intra- or subretinal fluid in either eye at the time of enrolment
- •-History of inactive CNV in study eye. Inactive CNV of fellow eye is allowed if treatment was performed more than 12 months before enrolment
- •-Any anti-VEGF or Verteporfin treatment in study eye and anti-VEGF or Verteporfin treatment less than 12 months before enrolment in fellow eye
- •-History of systemic anti-VEGF therapy
- •-Cataract that would prevent an accurate measurement of the axial length of the study eye
- •-Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrolment (e.g. PIC, Uveitis)
- •-Ocular disorders that may confound interpretation of research project results, compromise visual acuity or require medical or surgical intervention during the observation period (including retinal detachment, cataract and pre-retinal membrane of the macula)
- •-Ocular disorders which may lead to an ophthalmic surgery within 5 years
- •-Further retinal disorders such as retinopathia pigmentosa/centralis, diabetic maculopathy or Marfan syndrome
- •-Patients with inability to comply with the research project or follow up procedures
- •-Research project personnel or first degree relatives of investigator(s)
研究者
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