A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

This study has been terminated.

First Received: August 24, 2005 Last Updated: July 25, 2007 History of Changes

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00135655

Purpose

The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.

Condition	Intervention	Phase
Macular Edema, Cystoid	Drug: denufosol tetrasodium (INS37217) Intravitreal Injection	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Edema

Drug Information available for: Denufosol INS37217

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

safety
tolerability
retinal thickness
visual acuity

Estimated Enrollment:	15
Study Start Date:	August 2005

Eligibility

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

Criteria

Inclusion Criteria:

Have persistent post cataract extraction macular edema whose condition is stable
Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
Have at least one eligible eye to be treated in the study
Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
Have macular edema confirmed by fluorescein angiography

Exclusion Criteria:

Have proliferative vitreoretinopathy greater than grade B in either eye
Have ocular disorders in the study eye that may confound interpretation of study results
Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
Have had any ocular implant device for the delivery of therapeutic agents
Be taking any excluded medications that could obscure or confound study results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135655

Locations

United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Maryland
Johns Hopkins School of Medicine, Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9277
United States, New York
The New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Texas
Austin Retina Associates
Austin, Texas, United States, 78705

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

Inspire Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	06-104
Study First Received:	August 24, 2005
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00135655 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Inspire Pharmaceuticals:

macular edema
post cataract extraction
cystoid macular edema
post cataract extraction macular edema

Study placed in the following topic categories:

Signs and Symptoms
Macular Edema
Eye Diseases
Cataract
Retinal Degeneration

Macular Degeneration
Edema
Lens Diseases
Retinal Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Macular Edema
Eye Diseases
Cataract
Retinal Degeneration

Macular Degeneration
Edema
Lens Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009