A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment

Merck Sharp & Dohme LLC0 个研究点目标入组 14 人开始时间: 2001年5月1日最近更新: 2015年10月9日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 14
主要终点: tolerability

研究概览研究设计入排标准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

The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous retinal detachment (RRD).

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

入排标准

接受健康志愿者: 否

入选标准

•have macula-on or macula-off rhegmatogenous retinal detachment
•are eligible for pneumatic retinopexy, with identifiable retinal breaks
•are phakic or pseudo-phakic

排除标准

•have detachments not of a rhegmatogenous nature
•currently have blood in the vitreous, corneal opacity, or other conditions which limit the view of peripheral retina
•have evidence of intraocular inflammation (uveitis)
•have a history of current condition of uncontrollable, elevated IOP or open-angle glaucoma
•have breaks not conducive to a single procedure of pneumatic retinopexy treatment
•have proliferative vitreoretinopathy of type C or D
•have previously had a vitrectomy or require one
•have previously had a scleral buckle procedure

结局指标

主要结局

tolerability

次要结局

pharmacological activity

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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