EUCTR2005-001171-36-BE进行中（未招募）不适用
A Dose-Escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy - MIVI
ThromboGenics Ltd.0 个研究点目标入组 50 人开始时间: 2005年6月30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
- 50
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
- •INCLUSION CRITERIA
- •i. Male or female patients aged 18 to 80 years inclusive.
- •ii. Patients with vitreomacular traction maculopathy for whom vitrectomy is
- •indicated according to the principal investigator, including:
- •o Macular edema associated with vitreomacular traction (DME, VMTS)
- •o Stage II-III macular hole of < 6 months duration since symptom onset
- •iii Demonstration of vitreomacular adhesion (based on preoperative OCT) in the
- •o OCT - presence of posterior hyaloid membrane inserting on to the macula, but
- •with some area of clear separation visible between the retina and the posterior
- •iv 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
- •EXCLUSION CRITERIA
- •i. Evidence of fibrocellular proliferation characterized by whitish epimacular tissue
- •(Surface wrinkling is not an exclusion criterion).
- •ii. 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.
- •iii. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative
- •changes in the study eye.
- •iv. Patients with high myopia or aphakia in the study eye
- •v. Patients with history of,rhegmatogenous retinal detachment in the fellow eye or
- •family history of retinal detachment
- •vi. Patients who are considered likely to require intraocular surgery in the study eye
- •for any reason other than vitreomacular traction maculopathy/macular edema in
- •the coming three months.
- •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 a history of uveitis or significant trauma in the study eye.
- •x. Patients who are currently being treated for glaucoma in the study eye.
- •xi. Patients who have had laser photocoagulation treatment in the study eye in the
- •previous 3 months.
- •xii. Intravitreal injection of any drug in the study eye in the previous 6 months or
- •during the study.
- •xiii. Patients who are pregnant or of child-bearing potential not utilizing a form of
- •contraception acceptable to the Investigator.
- •xiv. Patients who in the investigators view will not complete all visits and
- •investigations, including the exit visit at 6 months.
- •xv. Patients who have participated in an investigational drug study within the past
- •xvi. HgA1c > 9%.
- •xvii. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg).
- •xviii. Patients with a life-expectancy less than 6 months.
- •xix. Patients who have previously participated in this trial.
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