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

Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00083967
• Other study ID #: 06-102
• Status: Terminated
• Phase: Phase 2
• First received: June 3, 2004
• Last updated: April 9, 2015
• Start date: June 2004
• Est. completion date: April 2006

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Drug:
• denufosol tetrasodium (INS37217) Intravitreal Injection

Locations

Country	Name	City	State
United States	Austin Retina	Austin	Texas
United States	Maine Vitreoretinal Consultants	Bangor	Maine
United States	Retina Associates of Cleveland	Beachwood	Ohio
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	New England Eye Center	Boston	Massachusetts
United States	National Retina Institute	Chevy Chase	Maryland
United States	The University of Chicago	Chicago	Illinois
United States	Cleveland Clinical Foundation	Cleveland	Ohio
United States	Retina Assocites of Cleveland, Inc.	Cleveland	Ohio
United States	Danbury Eye Physicians & Surgeons, P.C.	Danbury	Connecticut
United States	Kresge Eye Institute/Hutzel Hospital	Detroit	Michigan
United States	Retina Group of Florida	Ft. Lauderdale	Florida
United States	Vitreoretinal Consultants	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Illinois Retina Associates, S.C.	Joliet	Illinois
United States	Retina Associates	Kansas City	Missouri
United States	Retina Associates of Cleveland	Lakewood	Ohio
United States	University of Kentucky, The Kentucky Clinic	Lexington	Kentucky
United States	Retina Associates of Cleveland	Lorain	Ohio
United States	Retina Vitreous Associates Medical Group	Los Angeles	California
United States	Retina Associates of Cleveland	Middleburg Heights	Ohio
United States	Retina Associates of NJ	Millburn	New Jersey
United States	Medical College of Wisconsin/The Eye Institute	Milwaukee	Wisconsin
United States	NY Eye and Ear Infirmary	New York	New York
United States	Wagner Mandell Retina Center	Norfolk	Virginia
United States	Central Florida Retina	Orlando	Florida
United States	Scheie Eye Institute	Philadelphia	Pennsylvania
United States	Retina Consultants San Diego	Poway	California
United States	Carolina Eye Associates	Southern Pines	North Carolina
United States	Retina Associates of NJ	Teaneck	New Jersey
United States	Retina Center, P.C.	Tucson	Arizona
United States	Wagner Mandell Retina Center	Virginia Beach	Virginia
United States	Retina Associates of NJ	Wayne	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
Primary	Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects
Secondary	Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3
Secondary	Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment