Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment - Full Text View

Sponsor:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00083967

Purpose

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.

Condition	Intervention	Phase
Retinal Detachment	Drug: denufosol tetrasodium (INS37217) Intravitreal Injection	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Denufosol INS37217

U.S. FDA Resources

Further study details as provided by Inspire Pharmaceuticals:

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

Estimated Enrollment:	160
Study Start Date:	May 2004
Estimated Study Completion Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083967

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Locations

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

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

Unaffiliated

More Information

No publications provided

Study ID Numbers:	06-102
Study First Received:	June 3, 2004
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00083967 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inspire Pharmaceuticals:

rhegmatogenous retinal detachment
detached retina
retinal tear
retinal break

Additional relevant MeSH terms:

Retinal Detachment
Mental Disorders
Eye Diseases
Dissociative Disorders
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2009