NCT02951975终止不适用
Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 246
- 试验地点
- 21
- 主要终点
- Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters
研究概览
简要总结
This observational study will evaluate the safety, efficacy, characteristics of patients, characteristics of physicians and quality of life in patients who are prescribed OZURDEX® as treatment for non-infectious uveitis of the posterior segment of the eye in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient with non-infectious uveitis affecting the posterior segment of the eye.
排除标准
- •Patient not residing in metropolitan France.
研究组 & 干预措施
OZURDEX®
Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of non-infectious uveitis affecting the posterior segment of the eye.
干预措施: dexamethasone intravitreal implant (Drug)
结局指标
主要结局
Percentage of Participants with Best Corrected Visual Acuity (BCVA) ≥15 Letters
时间窗: 2 Months
次要结局
- Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline(Baseline, Months 6 and 18)
- Change from Baseline in Vitreous Haze Score Using a 5-Point Scale(Baseline and Months 2, 6 and 18)
- Change from Baseline in Macular Thickness(Baseline, Months 2, 6 and 18)
- Percentage of Participants Categorized by Comorbidities (Diseases Associated with Inflammation, Other Ophthalmic Diseases, General Comorbidities)(18 Months)
- Change from Baseline in the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ25) Score Using a 25 Item Questionnaire(Baseline, Months 2 and 18)
- Change from Baseline in BCVA(Baseline, Months 2, 6 and 18)
- Number of Repeat Treatments with OZURDEX® and Other Drugs(18 Months)
- Time Between Repeat Treatments with OZURDEX® and Other Drugs(18 Months)
- Percentage of Participants with Adverse Events (AEs)(18 Months)
研究者
研究点 (21)
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