跳至主要内容
临床试验/NCT02079883
NCT02079883已完成不适用

Ocriplasmin Research to Better Inform Treatment (ORBIT)

ThromboGenics110 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ThromboGenics
入组人数
540
试验地点
110
主要终点
Occurrence and time to vitrectomy

研究概览

简要总结

This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.

详细描述

The sites will prospectively enroll consecutive patients eligible for participation in the study. Informed consent will be obtained prior to any data being collected. This study is observational; therefore, all treatment decisions and assessments are at the discretion of the patient's treating physician and are not mandated by the study design or protocol. Patients will be enrolled at a routinely scheduled visit, on the day of JETREA® administration after the JETREA® injection. No specific visits, examinations, laboratory tests or procedures are mandated as part of this study. There is no pre-set visit schedule, and the frequency and timing of actual patient visits is at the discretion of the treating physician following standard of care. All available and relevant data will be collected prospectively.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18 years or older diagnosed with symptomatic VMA treated with JETREA ® at the physician's discretion in a manner consistent with the product label.
  • Willing and able to provide written informed consent

排除标准

  • Patients who are treated with JETREA® for medical conditions outside of the US product label.
  • Concurrent participation in a research study that prescribes ocular treatment, imaging and/or interventions

结局指标

主要结局

Occurrence and time to vitrectomy

时间窗: 12 months

Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.

时间窗: 12 Months

Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician

时间窗: 12 months

Mean change in visual acuity (VA) from baseline across time

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
ThromboGenics
申办方类型
Industry
责任方
Sponsor

研究点 (110)

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