OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 24
- 主要终点
- Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.
研究概览
简要总结
The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.
详细描述
This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of this study are to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of VMA with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms. The retrospective study will collect Heidelberg Spectralis® SD-OCT images which will be masked and uploaded to a Central Reading Center (CRC) for review and analysis. The CRC will evaluate anatomic endpoints of interest from both baseline optical coherence tomography (OCT) images and all follow-up OCT scans over the 6 month follow up period. Endpoints of interest include ellipsoid zone disruption, development of subretinal fluid, resolution of VMA and macular hole changes. Further, trained clinical personnel at the participating centers will transcribe data from the patients' records, to be entered into the study database.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Must be at least 18 years of age or older.
- •Have been treated with JETREA® for vitreomacular adhesion (VMA) between April 1, 2013 and December 31, 2013 with at least six months of follow up visits post injection. Note: If a patient's second eye was treated, only the first eye treated is eligible for study participation.
- •Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days prior to JETREA® injection.
- •Have been imaged with Heidelberg Spectralis SD-OCT at least two times post JETREA® injection with at least one scan between Days 1-21 and the second scan within six months,, including a corresponding visual acuity (VA).
- •Be willing and able to provide informed consent.
排除标准
- •Patients treated with JETREA® for medical conditions outside of the product label.
- •Patients with other retinal conditions that affect the vitreo-retinal interface, or can lead to retinal atrophy, including but not limited to:
- •Neovascular age-related macular degeneration;
- •Fibrovascular scar;
- •Diabetic macular edema; and
- •Proliferative diabetic retinopathy.
结局指标
主要结局
Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.
时间窗: Day 21
次要结局
- Proportion of patients with ellipsoid zone disruption, not present at baseline(Up to 6 months)
- Proportion of patients with ellipsoid zone disruption with resolution(Up to 6 months)
- Time to onset of ellipsoid zone disruption(Up to 6 months)
- Time to resolution of ellipsoid zone disruption(Up to 6 months)
- Proportion of patients with nonsurgical resolution of VMA by Day 28(Day 28)
- Proportion of patients that developed subretinal fluid, not present at baseline(Up to 6 months)
- Proportion of patients that developed subretinal fluid with resolution(Up to 6 months)
- Time to onset of subretinal fluid(Up to 6 months)
- Time to resolution of subretinal fluid(Up to 6 months)
- Time to resolution of VMA(Up to 6 months)
- Proportion of patients that developed a macular hole by Day 28, not present at baseline(Day 28)
- Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28(Day 28)
- Proportion of patients with worsening (enlargement) of macular hole, if present at baseline(Up to 6 months)
- No change of macular hole, if present at baseline(Up to 6 months)
- Proportion of patients that underwent vitrectomy(Up to 6 months)
- Visual Acuity (VA) changes from baseline(Up to 6 months)
- Other findings as examined and documented in the patient's medical records(Up to 6 months)
- Monitoring of Adverse Drug Reactions (ADRs)(Up to 6 motnths)