EUCTR2008-004393-40-CZ进行中（未招募）不适用
A randomized, placebo controlled, double-masked, multicenter trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion.
ThromboGenics NV0 个研究点目标入组 320 人开始时间: 2008年12月15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
- 入组人数
- 320
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
- •1. Male or female subjects aged = 18
- •2. Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
- •3. BCVA of 20/25 or worse in study eye
- •4. BCVA of 20/800 or better in the non-study eye
- •5. Written informed consent obtained from the subject prior to inclusion in the trial
- •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
- •1. Any evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative AMD or retinal vein occlusion in the study eye
- •2. Subjects with any vitreous hemorrhage or any other vitreous opacification 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
- •3. Subjects with macular hole diameter > 400 µm in the study eye
- •4. Aphakia in the study eye
- •5. High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).
- •6. Subjects with history of rhegmatogenous retinal detachment in either eye
- •7. Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months
- •8. Subjects who have had laser photocoagulation to the macula in the study eye at any time
- •9. Subjects with pseudo-exfoliation, Marfan’s syndrome, phacodenesis or any other finding in the investigator’s opinion suggesting lens/zonular instability
- •10. Subjects who have had a vitrectomy in the study eye at any time.
- •11. Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure = 26 mm Hg in spite of treatment with anti-glaucoma medication)
- •12. Subjects who are pregnant, breastfeeding, or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide.
- •13. Subjects who, in the Investigators view, will not complete all visits and investigations
- •14. Subjects who have participated in an investigational drug trial within the past 30 days
- •15. Subjects who have previously participated in this trial
研究者
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