NCT03953807已完成4 期
A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) With Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 82
- 试验地点
- 26
- 主要终点
- Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection
研究概览
简要总结
This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.
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
- •Prior diagnosis of diabetes mellitus (type 1 or type 2)
- •Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
- •Written informed consent obtained in accordance with all local privacy requirements
排除标准
- •Uncontrolled systemic disease
- •History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications
- •Patients who have been previously treated for DME (two focal laser allowed)
- •Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
- •Elevated IOP or glaucoma diagnosis
- •Any active ocular infection or inflammation
- •A substantial cataract is present that is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing visual acuity to 20/40 or worse if the eye was otherwise normal)
- •Anticipated need for ocular surgery during the study
- •History of vitrectomy or incisional glaucoma surgery - Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
- •Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine
研究组 & 干预措施
Ozurdex
Experimental
OZURDEX implant 700 μg
干预措施: Dexamethasone Intravitreal Implant (Drug)
结局指标
主要结局
Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection
时间窗: Baseline, at Month 10 through 12
次要结局
- Time to 3rd injection(During the 12 to 14-month study)
- AUC for BCVA(Baseline, During the 12 to 14-month study)
- Mean number of injections administered(During the 12- to 14-month study)
- Mean retreatment interval in months(During the 12 to 14-month study)
- Area under the curve (AUC) for CRT(Baseline, During the 12 to 14-month study)
- Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)(Baseline, at Month 14)
- Proportion of patients with 2nd injection(During the 12 to 14-month study)
- Proportion of patients with 3rd injection(During the 12 to 14-month study)
- Time to 2nd injection(During the 12 to 14-month study)
- Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received(Baseline, at Month 10 through 12)
研究者
研究点 (26)
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