High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)

Novartis Pharmaceuticals1 个研究点分布在 1 个国家目标入组 153 人2014年6月12日

适应症Pathologic Myopia

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Pathologic Myopia
发起方: Novartis Pharmaceuticals
入组人数: 153
试验地点: 1
主要终点: Change in retinal morphology by SD-OCT
状态: 已完成
最后更新: 6年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This research project intends to observe patients with high myopia who show pathological retinal changes, in order to evaluate more data on the risk factors for developing mCNV within this research project population in Germany.

注册库

clinicaltrials.gov

开始日期

2014年6月12日

结束日期

2019年5月23日

最后更新

6年前

研究类型

Observational

性别

All

研究者

发起方

Novartis Pharmaceuticals

责任方

Sponsor

入排标准

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 of the protocol in the investigator's discretion confirmed by the reading centre

排除标准

•Patients with Diabetes mellitus of any grade
•Patients showing signs of Age-Related Macular Degeneration (AMD), e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exudative 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 vascular endothelial growth factor' (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 vascular endothelial growth factor' (anti-VEGF) therapy
•Cataract that would prevent an accurate measurement of the axial length of the study eye
•Other protocol-defined inclusion/exclusion criteria may apply

结局指标

主要结局

Change in retinal morphology by SD-OCT

时间窗: Baseline, first year, 2nd year, 3rd year

To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV by measuring the change in retinal morphology with spectral domain optical coherence tomography (SD-OCT). Risk factors are defined as choroidal thinning \< 50μm, choroidal curvature length \> 6300 μm (nasal temporal), lacquer cracks, patchy atrophy \> 5mm² and preexisting myopic CNV in second eye.

次要结局

Change in retinal morphology by fundus autofluorescence(Baseline, first year, 2nd year, 3rd year)
Change in retinal morphology by fundus photography(Baseline, first year, 2nd year, 3rd year)
Change in refraction error by autorefractometer(Baseline, 3rd year)
Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)(Baseline, 3rd year)