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

Stopped early · Phase 2

Conditions studied: Retinal Detachment

In brief

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.

Key facts

Study ID

NCT00083967

Run by

Merck Sharp & Dohme LLC

People needed

23

Starts

2004-06-01

Expected to finish

2006-04-01

Last updated by the study team

2015-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retina Center, P.C. — Tucson, Arizona, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Retina Vitreous Associates Medical Group — Los Angeles, California, United States
• Retina Consultants San Diego — Poway, California, United States
• Danbury Eye Physicians & Surgeons, P.C. — Danbury, Connecticut, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Central Florida Retina — Orlando, Florida, United States
• The University of Chicago — Chicago, Illinois, United States
• Illinois Retina Associates, S.C. — Joliet, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, 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 — Millburn, New Jersey, United States
• Retina Associates of NJ — Teaneck, New Jersey, United States
• Retina Associates of NJ — Wayne, New Jersey, United States
• NY Eye and Ear Infirmary — New York, New York, United States
• Carolina Eye Associates — Southern Pines, North Carolina, United States
• Retina Associates of Cleveland — Beachwood, Ohio, United States
• Retina Assocites of Cleveland, Inc. — Cleveland, Ohio, United States
• Cleveland Clinical Foundation — Cleveland, Ohio, United States
• Retina Associates of Cleveland — Lakewood, Ohio, United States

Full record on ClinicalTrials.gov

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