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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denufosol tetrasodium (INS37217) Intravitreal Injection | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo | ||
| Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Schaberg, BSN | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Center, P.C. | Tucson | Arizona | 85704 | United States | ||
| Retina-Vitreous Associates Medical Group |
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| Beverly Hills |
| California |
| 90211 |
| United States |
| Retina Vitreous Associates Medical Group | Los Angeles | California | 90017 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| Danbury Eye Physicians & Surgeons, P.C. | Danbury | Connecticut | 06810 | United States |
| Retina Group of Florida | Fort Lauderdale | Florida | 33334 | United States |
| Central Florida Retina | Orlando | Florida | 32806 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| Illinois Retina Associates, S.C. | Joliet | Illinois | 60435 | 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 | Millburn | New Jersey | 07041 | United States |
| Retina Associates of NJ | Teaneck | New Jersey | 07666 | 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 Associates of Cleveland | Beachwood | Ohio | 44122 | United States |
| Retina Assocites of Cleveland, Inc. | Cleveland | Ohio | 44107 | United States |
| Cleveland Clinical Foundation | Cleveland | Ohio | 44195 | United States |
| Retina Associates of Cleveland | Lakewood | Ohio | 44107 | United States |
| Retina Associates of Cleveland | Lorain | Ohio | 44052 | United States |
| Retina Associates of Cleveland | Middleburg Heights | Ohio | 44130 | 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 | Norfolk | Virginia | 23505 | United States |
| Wagner Mandell Retina Center | Virginia Beach | Virginia | 23454 | United States |
| Medical College of Wisconsin/The Eye Institute | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C465279 | denufosol tetrasodium |
| D058449 | Intravitreal Injections |
| ID | Term |
|---|---|
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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