A Study in Subjects With Retinal Detachment

This study has been completed.

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00210067

Purpose

The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous retinal detachment (RRD).

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

Drug Information available for: INS37217 Denufosol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

tolerability

Secondary Outcome Measures:

pharmacological activity

Estimated Enrollment:	22
Study Start Date:	March 2001

Eligibility

Criteria

Inclusion Criteria:

have macula-on or macula-off rhegmatogenous retinal detachment
are eligible for pneumatic retinopexy, with identifiable retinal breaks
are phakic or pseudo-phakic

Exclusion Criteria:

have detachments not of a rhegmatogenous nature
currently have blood in the vitreous, corneal opacity, or other conditions which limit the view of peripheral retina
have evidence of intraocular inflammation (uveitis)
have a history of current condition of uncontrollable, elevated IOP or open-angle glaucoma
have breaks not conducive to a single procedure of pneumatic retinopexy treatment
have proliferative vitreoretinopathy of type C or D
have previously had a vitrectomy or require one
have previously had a scleral buckle procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210067

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Amy Schaberg, BSN

Unaffiliated

More Information

Study ID Numbers:	06-101
Study First Received:	September 13, 2005
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00210067
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Retinal Detachment
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009