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

April 9, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Retina Center, P.C.
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Los Angeles, California, United States, 90017
        • Retina Vitreous Associates Medical Group
      • Poway, California, United States, 92064
        • Retina Consultants San Diego
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Eye Physicians & Surgeons, P.C.
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Retina Group of Florida
      • Orlando, Florida, United States, 32806
        • Central Florida Retina
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • Joliet, Illinois, United States, 60435
        • Illinois Retina Associates, S.C.
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Midwest Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, The Kentucky Clinic
    • Maine
      • Bangor, Maine, United States, 04401
        • Maine Vitreoretinal Consultants
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • National Retina Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • New England Eye Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute/Hutzel Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Retina Associates
    • New Jersey
      • Millburn, New Jersey, United States, 07041
        • Retina Associates of NJ
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates of NJ
      • Wayne, New Jersey, United States, 07470
        • Retina Associates of NJ
    • New York
      • New York, New York, United States, 10003
        • NY Eye and Ear Infirmary
    • North Carolina
      • Southern Pines, North Carolina, United States, 28387
        • Carolina Eye Associates
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Retina Associates of Cleveland
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinical Foundation
      • Cleveland, Ohio, United States, 44107
        • Retina Assocites of Cleveland, Inc.
      • Lakewood, Ohio, United States, 44107
        • Retina Associates of Cleveland
      • Lorain, Ohio, United States, 44052
        • Retina Associates of Cleveland
      • Middleburg Heights, Ohio, United States, 44130
        • Retina Associates of Cleveland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Retina
      • Houston, Texas, United States, 77030
        • Vitreoretinal Consultants
    • Virginia
      • Norfolk, Virginia, United States, 23505
        • Wagner Mandell Retina Center
      • Virginia Beach, Virginia, United States, 23454
        • Wagner Mandell Retina Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin/The Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have rhegmatogenous retinal detachment in only one eye
  • be able to receive intravitreal injection of study drug and be able to wait 24(+/- 6) hours to have detachment surgically treated or retinal breaks repaired per judgement of investigator
  • no more than 3 separate identifiable retinal breaks that are clustered together and confined within an area no more than 2 clock hours in extent
  • retinal detachment must be large enough such that it cannot be immediately repaired with laser photocoagulation or cryotherapy
  • have pinhole acuity (using ETDRS) of macula-on, 20/50 or better in both eyes OR macula-off, 20/50 or better in non-study eye and have history, prior to detachment, of reading capability in study eye

Exclusion Criteria:

  • have a non-rhegmatogenous retinal detachment
  • have large retinal break(s) whose total break area is greater than 1 clock hour in extent
  • have evidence of atrophic retinal pigment epithelium, choroid, choroidal detachment or intraocular inflammation
  • be monocular
  • have a prior retinal detachment repair or a congenital condition that places a greater risk for rhegmatogenous retinal detachment
  • have proliferative vitreoretinopathy greater than grade B
  • have pre-existing subretinal or vitreous hemorrhage, corneal opacity, or other conditions which limit the view of peripheral retina
  • have any co-existing macular pathology or other retinal conditions that can limit visual acuity
  • currently have uncontrollable elevated intraocular pressure, advanced glaucoma, or any history or current evidence of endophthalmitis in the affected eye
  • have symptoms consistent with a rhegmatogenous retinal detachment such as visual disturbance greater than 14 days prior to screening if macula-on OR history of loss of reading vision in affected eye for greater than 6 days prior to screening if macula-off
  • have a retinal detachment with evidence of demarcation lines or evidence of subretinal fibrosis visible upon fundus examination
  • be currently taking medications that could obscure or confound study results including acetazolamide (Diamox) and dorzolamide
  • have had a periocular, retrobulbar or intravitreal injection in the affected eye, including corticosteroids in the 3 months prior to screening or require one

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

June 3, 2004

First Submitted That Met QC Criteria

June 4, 2004

First Posted (Estimate)

June 7, 2004

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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