临床试验/NCT01229215

NCT01229215已完成2 期

A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy

Genentech, Inc.0 个研究点目标入组 143 人开始时间: 2011年2月最近更新: 2016年11月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Genentech, Inc.
入组人数: 143
主要终点: Growth rate of geographic atrophy (GA) lesion area from baseline

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.

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: Single (Participant)

入排标准

年龄范围: 60 Years 至 89 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
•Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

排除标准

•History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
•Previous subfoveal focal laser photocoagulation in the study eye
•Laser photocoagulation in the study eye
•Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
•GA in either eye due to causes other than AMD
•Diabetic retinopathy in either eye
•Active or history of wet AMD in either eye
•History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
•Active malignancy or history of malignancy within the past 5 years
•Previous participation in any studies of investigational drugs within 3 months preceding Day 0

研究组 & 干预措施

FCFD4514S

Experimental

干预措施: FCFD4514S (Drug)

sham

Sham Comparator

干预措施: sham (Drug)

结局指标

主要结局

Growth rate of geographic atrophy (GA) lesion area from baseline

时间窗: Month 18

次要结局

Mean change in best corrected visual acuity (BCVA) from baseline(Month 18)

研究者

发起方

Genentech, Inc.

申办方类型

Industry

责任方

Sponsor

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