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.
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
Retina Center, P.C., Tucson, Arizona 85704, United States
Retina Consultants San Diego, Poway, California 92064, United States
Retina-Vitreous Associates Medical Group, Beverly Hills, California 90211, United States
Retina Vitreous Associates Medical Group, Los Angeles, California 90017, United States
Danbury Eye Physicians & Surgeons, P.C., Danbury, Connecticut 06810, United States
Central Florida Retina, Orlando, Florida 32806, United States
Retina Group of Florida, Ft. Lauderdale, Florida 33334, United States
Illinois Retina Associates, S.C., Joliet, Illinois 60435, United States
The University of Chicago, Chicago, Illinois 60637, United States
Midwest Eye Institute, Indianapolis, Indiana 46280, United States
University of Kentucky, The Kentucky Clinic, Lexington, Kentucky 40536, United States
Maine Vitreoretinal Consultants, Bangor, Maine 04401, United States
National Retina Institute, Chevy Chase, Maryland 20815, United States
New England Eye Center, Boston, Massachusetts 02111, United States
Kresge Eye Institute/Hutzel Hospital, Detroit, Michigan 48201, United States
Retina Associates, Kansas City, Missouri 64111, United States
Retina Associates of NJ, Teaneck, New Jersey 07666, United States
Retina Associates of NJ, Millburn, New Jersey 07041, United States
Retina Associates of NJ, Wayne, New Jersey 07470, United States
NY Eye and Ear Infirmary, New York, New York 10003, United States
Carolina Eye Associates, Southern Pines, North Carolina 28387, United States
Retina Assocites of Cleveland, Inc., Cleveland, Ohio 44107, United States
Retina Associates of Cleveland, Lakewood, Ohio 44107, United States
Retina Associates of Cleveland, Middleburg Heights, Ohio 44130, United States
Retina Associates of Cleveland, Lorain, Ohio 44052, United States
Retina Associates of Cleveland, Beachwood, Ohio 44122, United States
Cleveland Clinical Foundation, Cleveland, Ohio 44195, United States
Scheie Eye Institute, Philadelphia, Pennsylvania 19104, United States
Austin Retina, Austin, Texas 78705, United States
Vitreoretinal Consultants, Houston, Texas 77030, United States
Wagner Mandell Retina Center, Virginia Beach, Virginia 23454, United States
Wagner Mandell Retina Center, Norfolk, Virginia 23505, United States
Medical College of Wisconsin/The Eye Institute, Milwaukee, Wisconsin 53226, United States
