Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
- Conditions
- Retinal Detachment
- Registration Number
- NCT00083967
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (27)
Retina Assocites of Cleveland, Inc.
🇺🇸Cleveland, Ohio, United States
Cleveland Clinical Foundation
🇺🇸Cleveland, Ohio, United States
Retina Vitreous Associates Medical Group
🇺🇸Los Angeles, California, United States
Retina Center, P.C.
🇺🇸Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Danbury Eye Physicians & Surgeons, P.C.
🇺🇸Danbury, Connecticut, United States
Retina Group of Florida
🇺🇸Ft. Lauderdale, Florida, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Illinois Retina Associates, S.C.
🇺🇸Joliet, Illinois, United States
University of Kentucky, The Kentucky Clinic
🇺🇸Lexington, Kentucky, United States
Maine Vitreoretinal Consultants
🇺🇸Bangor, Maine, United States
National Retina Institute
🇺🇸Chevy Chase, Maryland, United States
New England Eye Center
🇺🇸Boston, Massachusetts, United States
Kresge Eye Institute/Hutzel Hospital
🇺🇸Detroit, Michigan, United States
Retina Associates
🇺🇸Kansas City, Missouri, United States
Retina Associates of NJ
🇺🇸Wayne, New Jersey, United States
Carolina Eye Associates
🇺🇸Southern Pines, North Carolina, United States
Retina Associates of Cleveland
🇺🇸Middleburg Heights, Ohio, United States
Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Vitreoretinal Consultants
🇺🇸Houston, Texas, United States
Austin Retina
🇺🇸Austin, Texas, United States
Wagner Mandell Retina Center
🇺🇸Virginia Beach, Virginia, United States
Medical College of Wisconsin/The Eye Institute
🇺🇸Milwaukee, Wisconsin, United States
NY Eye and Ear Infirmary
🇺🇸New York, New York, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Central Florida Retina
🇺🇸Orlando, Florida, United States