A Study in Subjects With Retinal Detachment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00210067
First received: September 13, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Retinal Detachment
Drug: denufosol tetrasodium (INS37217) Intravitreal Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • tolerability

Secondary Outcome Measures:
  • pharmacological activity

Enrollment: 14
Study Start Date: May 2001
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
  Eligibility

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210067

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Amy Schaberg, BSN
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00210067     History of Changes
Other Study ID Numbers: 06-101
Study First Received: September 13, 2005
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinal Detachment
Dissociative Disorders
Retinal Diseases
Eye Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014