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.

Condition	Treatment or Intervention	Phase
Retinal Detachment	Drug: denufosol tetrasodium (INS37217)	Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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 introcular 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

Michelle Widmann      877-800-4536    mwidmann@inspirepharm.com

Arizona
      Retina Center, P.C., Tucson,  Arizona,  85704,  United States; Recruiting
California
      Retina Consultants San Diego, Poway,  California,  92064,  United States; Recruiting
      Retina-Vitreous Associates Medical Group, Beverly Hills,  California,  90211,  United States; Recruiting
      Retina Vitreous Associates Medical Group, Los Angeles,  California,  90017,  United States; Recruiting
Connecticut
      Danbury Eye Physicians & Surgeons, P.C., Danbury,  Connecticut,  06810,  United States; Recruiting
Florida
      Central Florida Retina, Orlando,  Florida,  32806,  United States; Recruiting
Illinois
      Illinois Retina Associates, S.C., Joliet,  Illinois,  60435,  United States; Recruiting
Indiana
      Midwest Eye Institute, Indianapolis,  Indiana,  46280,  United States; Recruiting
Maine
      Maine Vitreoretinal Consultants, Bangor,  Maine,  04401,  United States; Recruiting
Maryland
      National Retina Institute, Chevy Chase,  Maryland,  20815,  United States; Recruiting
Missouri
      Retina Associates, Kansas City,  Missouri,  64111,  United States; Recruiting
New Jersey
      Retina Associates of NJ, Teaneck,  New Jersey,  07666,  United States; Recruiting
      Retina Associates of NJ, Millburn,  New Jersey,  07041,  United States; Recruiting
      Retina Associates of NJ, Wayne,  New Jersey,  07470,  United States; Recruiting
New York
      NY Eye and Ear Infirmary, New York,  New York,  10003,  United States; Recruiting
North Carolina
      Carolina Eye Associates, Southern Pines,  North Carolina,  28387,  United States; Recruiting
Ohio
      Retina Assocites of Cleveland, Inc., Cleveland,  Ohio,  44107,  United States; Recruiting
      Retina Associates of Cleveland, Lakewood,  Ohio,  44107,  United States; Recruiting
      Retina Associates of Cleveland, Middleburg Heights,  Ohio,  44130,  United States; Recruiting
      Retina Associates of Cleveland, Lorain,  Ohio,  44052,  United States; Recruiting
      Retina Associates of Cleveland, Beachwood,  Ohio,  44122,  United States; Recruiting
Texas
      Austin Retina, Austin,  Texas,  78705,  United States; Recruiting
      Vitreoretinal Consultants, Houston,  Texas,  77030,  United States; Recruiting
Virginia
      Wagner Mandell Retina Center, Virginia Beach,  Virginia,  23454,  United States; Recruiting
      Wagner Mandell Retina Center, Norfolk,  Virginia,  23505,  United States; Recruiting
Wisconsin
      Medical College of Wisconsin/The Eye Institute, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study ID Numbers:  06-102
Record last reviewed:  September 2004
Record first received:  June 3, 2004
ClinicalTrials.gov Identifier:  NCT00083967
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10