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A Study in Subjects With Retinal Detachment

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ClinicalTrials.gov Identifier: NCT00210067
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Retinal Detachment Drug: denufosol tetrasodium (INS37217) Intravitreal Injection Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2001
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. tolerability

Secondary Outcome Measures :
  1. pharmacological activity


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210067


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00210067     History of Changes
Other Study ID Numbers: 06-101
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: October 2015

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