Clinical Trial: Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Rhegmatogenous

Brief Summary: The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.

Detailed Summary: The purpose of this trial is to determine if administration of denufosol is well-tolerated and more efficacious than placebo in stimulating subretinal fluid reabsorption and retinal reattachment without surgical intervention in subjects presenting with rhegmatogenous retinal detachment.
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
  • Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects


Original Primary Outcome:

  • Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
  • Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects
  • Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3
  • Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment


Current Secondary Outcome:

  • Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3
  • Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: June 3, 2004
Date Started: June 2004
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015