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

Primary Purpose

Retinal Detachment

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
denufosol tetrasodium (INS37217) Intravitreal Injection
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring rhegmatogenous retinal detachment, detached retina, retinal tear, retinal break

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Center, P.C.
  • Retina-Vitreous Associates Medical Group
  • Retina Vitreous Associates Medical Group
  • Retina Consultants San Diego
  • Danbury Eye Physicians & Surgeons, P.C.
  • Retina Group of Florida
  • Central Florida Retina
  • The University of Chicago
  • Illinois Retina Associates, S.C.
  • Midwest Eye Institute
  • University of Kentucky, The Kentucky Clinic
  • Maine Vitreoretinal Consultants
  • National Retina Institute
  • New England Eye Center
  • Kresge Eye Institute/Hutzel Hospital
  • Retina Associates
  • Retina Associates of NJ
  • Retina Associates of NJ
  • Retina Associates of NJ
  • NY Eye and Ear Infirmary
  • Carolina Eye Associates
  • Retina Associates of Cleveland
  • Retina Assocites of Cleveland, Inc.
  • Cleveland Clinical Foundation
  • Retina Associates of Cleveland
  • Retina Associates of Cleveland
  • Retina Associates of Cleveland
  • Scheie Eye Institute
  • Austin Retina
  • Vitreoretinal Consultants
  • Wagner Mandell Retina Center
  • Wagner Mandell Retina Center
  • Medical College of Wisconsin/The Eye Institute

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 3, 2004
Last Updated
April 9, 2015
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00083967
Brief Title
Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
rhegmatogenous retinal detachment, detached retina, retinal tear, retinal break

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
denufosol tetrasodium (INS37217) Intravitreal Injection
Primary Outcome Measure Information:
Title
Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
Title
Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects
Secondary Outcome Measure Information:
Title
Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3
Title
Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Schaberg, BSN
Official's Role
Study Director
Facility Information:
Facility Name
Retina Center, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Danbury Eye Physicians & Surgeons, P.C.
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Retina Group of Florida
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Central Florida Retina
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Illinois Retina Associates, S.C.
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
University of Kentucky, The Kentucky Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Maine Vitreoretinal Consultants
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
National Retina Institute
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
New England Eye Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Kresge Eye Institute/Hutzel Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Retina Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Retina Associates of NJ
City
Millburn
State/Province
New Jersey
ZIP/Postal Code
07041
Country
United States
Facility Name
Retina Associates of NJ
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Retina Associates of NJ
City
Wayne
State/Province
New Jersey
ZIP/Postal Code
07470
Country
United States
Facility Name
NY Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Carolina Eye Associates
City
Southern Pines
State/Province
North Carolina
ZIP/Postal Code
28387
Country
United States
Facility Name
Retina Associates of Cleveland
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Retina Assocites of Cleveland, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Cleveland Clinical Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina Associates of Cleveland
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Retina Associates of Cleveland
City
Lorain
State/Province
Ohio
ZIP/Postal Code
44052
Country
United States
Facility Name
Retina Associates of Cleveland
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Austin Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wagner Mandell Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23505
Country
United States
Facility Name
Wagner Mandell Retina Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Medical College of Wisconsin/The Eye Institute
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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