NCT02322229已完成4 期
Assessment of Anatomical and Functional Outcomes in Subjects Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation
研究概览
简要总结
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of VMT/sVMA, with evidence of focal VMT visible on Spectral Domain - Optical Coherence Tomography (SD-OCT).
- •Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
- •Willing and able to attend all study visits.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •Hypersensitivity to ocriplasmin or any of the JETREA™® excipients.
- •Active or suspected intraocular or periocular infection in either eye.
- •Participation in any interventional clinical trial within 30 days prior to baseline.
- •Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.
- •Broad VMT/VMA > 1500 microns at baseline in the study eye.
- •History of vitrectomy in the study eye.
- •History of laser photocoagulation to the macula in the study eye.
- •Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period.
- •Macular hole of > 400 microns diameter in the study eye.
- •High myopia in the study eye.
- •Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator's opinion, suggests lens/zonular instability.
- •Aphakia in the study eye.
- •History of retinal detachment in the study eye.
- •Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy).
- •Proliferative diabetic retinopathy or ischemic retinopathies in the study eye.
- •Retinal vein occlusions in the study eye.
- •Exudative age-related macular degeneration (AMD) in the study eye.
- •Vitreous hemorrhage in the study eye.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Ocriplasmin
Experimental
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
干预措施: Ocriplasmin 0.125 mg in a 0.1 mL volume (Drug)
结局指标
主要结局
Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation
时间窗: Day 28
Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. One eye (study eye) contributed to the analysis.
次要结局
- Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180(Baseline (Day 0), Day 7, Day 28, Day 90, Day 180)
- Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)(Day 7, Day 28, Day 90, Day 180)
- Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180(Baseline (Day 0), Day 7, Day 90, Day 180)
- Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180(Day 180)
- Change From Baseline in Central Foveal Thickness at Days 28 and 180(Baseline (Day 0), Day 28, Day 180)
研究者
研究点 (1)
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