EUCTR2008-005228-10-BE进行中（未招募）不适用
An Open Label, Single Center Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion - MIVI 8
ThromboGenics NV0 个研究点开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •I. Male or female patients aged >= 18
- •II. Presence of focal vitreomacular adhesion (ie, central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex
- •III. BCVA of 20/32 or worse in the study eye
- •IV. BCVA of 20/400 or better in the contralateral eye
- •V. Written informed consent obtained from the patient prior to inclusion in the study
- •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
排除标准
- •I. Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection
- •II. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye
- •III. Patients with vitreous hemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye
- •IV. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes associated with increased risk of retinal detachment in the study eye. Such retinal degenerative changes include lattice degeneration or cystic retinal tufts. Thorough retinal examination should be performed in all patients to rule out these changes.
- •V. Patients with high myopia (> 8D) or aphakia in the study eye.
- •VI. Patients with history of rhegmatogenous retinal detachment in the fellow eye
- •VII. Patients who have had ocular surgery in the study eye in the prior three months
- •VIII. Patients who have had a vitrectomy in the study eye at any time.
- •IX. Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss, documented by perimetry, in the study eye
- •X. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months
- •XI. Intravitreal injection of any drug in the study eye in the previous 3 months
- •XII. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator
- •XIII. Patients who, in the investigators view, will not complete all visits and investigations, including the last visit at 6 months after the last injection
- •XIV. Patients who have participated in an investigational drug study within the past 30 days
- •XV. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg)
- •XVI. Patients with a life expectancy less than 6 months
- •XVII. Patients who have previously participated in this trial
研究者
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