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OpenTrials
Completed

NCT Number: NCT00210067

A Study in Subjects With Retinal Detachment

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).

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Study type

Interventional

Phase

Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

denufosol tetrasodium (INS37217) Intravitreal Injection

Drug

Primary outcomes

  1. tolerability

Secondary outcomes

  1. pharmacological activity

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Sep 21, 2005
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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