A Multicenter, Randomized, Masked, Controlled Study to Evaluate Retisert, and Intravitreal Fluocinolone Acetonide Implant, in the Treatment of Patients With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage
研究概览
简要总结
This was a multi-center, randomized, masked, parallel-group, controlled study in patients with diabetic macular edema, comparing RetisertTM (0.59 mg) with control therapy (standard of care (SOC) - repeat macular grid laser or observation). The objective was to evaluate the safety and efficacy of the intravitreal fluocinolone acetonide implant in the treatment of patients with diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Males and nonpregnant females at least 18 years of age, with DME in the study eye
- •Edema must involve fixation and be at least 1 disc area in size
- •Visual acuity of ≥20 and ≤68 letters by ETDRS in the study eye
- •The study eye must have received at least one macular laser treatment > 12 weeks prior to entry into the study
- •Ability and willingness to comply with treatment and follow-up
- •Ability to understand and sign the Informed Consent form
排除标准
- •Pregnant, lactating females
- •Allergy to fluocinolone acetonide or any component of the delivery system
- •Any disease or condition that would preclude study treatment or follow up
- •Presence at screening of IOP greater or equal to 22 mm HG while on antiglaucoma medication(s).
- •History of uncontrolled IOP within the last 12 months
研究组 & 干预措施
Fluocinolone acetonide
Fluocinolone acetonide intravitreal implant
干预措施: fluocinolone acetonide (Drug)
Standard of Care
Standard of care
干预措施: Standard of Care (Procedure)
结局指标
主要结局
A change from baseline in visual acuity using ETDRS charts • Humphrey Visual Field Mean Defect (24-2) • Masked reading of the size of the area of retinal thickening on color photographs and OCT, where available, and of severity of fluorescein leakage
时间窗: at 26 weeks and yearly through completion of the study
次要结局
未报告次要终点