Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
NCT ID: NCT00083967
Last Updated: 2015-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2004-06-30
2006-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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denufosol tetrasodium (INS37217) Intravitreal Injection
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Schaberg, BSN
Role: STUDY_DIRECTOR
Locations
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Retina Center, P.C.
Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Vitreous Associates Medical Group
Los Angeles, California, United States
Retina Consultants San Diego
Poway, California, United States
Danbury Eye Physicians & Surgeons, P.C.
Danbury, Connecticut, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Central Florida Retina
Orlando, Florida, United States
The University of Chicago
Chicago, Illinois, United States
Illinois Retina Associates, S.C.
Joliet, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
University of Kentucky, The Kentucky Clinic
Lexington, Kentucky, United States
Maine Vitreoretinal Consultants
Bangor, Maine, United States
National Retina Institute
Chevy Chase, Maryland, United States
New England Eye Center
Boston, Massachusetts, United States
Kresge Eye Institute/Hutzel Hospital
Detroit, Michigan, United States
Retina Associates
Kansas City, Missouri, United States
Retina Associates of NJ
Millburn, New Jersey, United States
Retina Associates of NJ
Teaneck, New Jersey, United States
Retina Associates of NJ
Wayne, New Jersey, United States
NY Eye and Ear Infirmary
New York, New York, United States
Carolina Eye Associates
Southern Pines, North Carolina, United States
Retina Associates of Cleveland
Beachwood, Ohio, United States
Retina Assocites of Cleveland, Inc.
Cleveland, Ohio, United States
Cleveland Clinical Foundation
Cleveland, Ohio, United States
Retina Associates of Cleveland
Lakewood, Ohio, United States
Retina Associates of Cleveland
Lorain, Ohio, United States
Retina Associates of Cleveland
Middleburg Heights, Ohio, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Austin Retina
Austin, Texas, United States
Vitreoretinal Consultants
Houston, Texas, United States
Wagner Mandell Retina Center
Norfolk, Virginia, United States
Wagner Mandell Retina Center
Virginia Beach, Virginia, United States
Medical College of Wisconsin/The Eye Institute
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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06-102
Identifier Type: -
Identifier Source: org_study_id
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