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 8, 2014
Last verified: October 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinal Detachment
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014