Assessment of Anatomical and Functional Outcomes in Patients Treated With Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 628
- 主要终点
- Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) 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 follow-up period.
详细描述
After receiving a single intravitreal injection as per country's product label (Day 0), subjects were followed for a 6-month period (Day 180).
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 vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMA visible on Spectral Domain Optical Coherence Tomography (SD-OCT).
- •Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential if pregnant, 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.
- •Presence of Epiretinal Membrane (ERM) over the macula at baseline.
- •Broad VMT/VMA >1500 microns at baseline.
- •History of vitrectomy in the study eye.
- •History of laser photocoagulation to the macula in the study eye.
- •Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period.
- •Macular hole of >400µm diameter in the study eye.
- •High myopia in the study eye.
- •Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens/zonular instability.
- •History of retinal detachment.
- •Diabetic retinopathy, ischaemic retinopathies, retinal vein occlusions.
- •Recent ocular surgery or ocular injection.
- •Vitreous hemorrhage.
- •Exudative age-related macular degeneration (AMD).
- •Therapy with another investigational agent within 30 days prior to Visit
- •Active, simultaneous enrollment in another ophthalmology clinical study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Ocriplasmin
Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
干预措施: Ocriplasmin (Drug)
结局指标
主要结局
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation
时间窗: Baseline, Day 28
Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. 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. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.
次要结局
- Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline(Day 28, Day 90, Day 180)
- Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA(Baseline, Day 90, Day 180)
- Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180(Day 180)
- Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)(Baseline (Day 0), Day 28, Day 180)
- Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance(Baseline (Day 0), Day 28, Day 90, Day 180)