Clinical trial NCT00083967: Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Retinal Detachment
Keywords: rhegmatogenous retinal detachment
detached retina
retinal tear
retinal break
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-06-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
measure: Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects
Secondary outcomes:
measure: Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3
measure: Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Retina Center, P.C.
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Los Angeles
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons, P.C.
state: Connecticut
city: Ft. Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Orlando
country: United States
facility: Central Florida Retina
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Illinois Retina Associates, S.C.
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky, The Kentucky Clinic
state: Kentucky
city: Bangor
country: United States
facility: Maine Vitreoretinal Consultants
state: Maine
city: Chevy Chase
country: United States
facility: National Retina Institute
state: Maryland
city: Boston
country: United States
facility: New England Eye Center
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute/Hutzel Hospital
state: Michigan
city: Kansas City
country: United States
facility: Retina Associates
state: Missouri
city: Millburn
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Wayne
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: New York
country: United States
facility: NY Eye and Ear Infirmary
state: New York
city: Southern Pines
country: United States
facility: Carolina Eye Associates
state: North Carolina
city: Beachwood
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Retina Assocites of Cleveland, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinical Foundation
state: Ohio
city: Lakewood
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Lorain
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Middleburg Heights
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: Scheie Eye Institute
state: Pennsylvania
city: Austin
country: United States
facility: Austin Retina
state: Texas
city: Houston
country: United States
facility: Vitreoretinal Consultants
state: Texas
city: Norfolk
country: United States
facility: Wagner Mandell Retina Center
state: Virginia
city: Virginia Beach
country: United States
facility: Wagner Mandell Retina Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin/The Eye Institute
state: Wisconsin
Study officials:
name: Amy Schaberg, BSN
role: STUDY_DIRECTOR
References: