Ocriplasmin Research to Better Inform Treatment (ORBIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 否
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
