Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
Retinal Detachment
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring rhegmatogenous retinal detachment, detached retina, retinal tear, retinal break
Eligibility 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 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
Sites / Locations
- Retina Center, P.C.
- Retina-Vitreous Associates Medical Group
- Retina Vitreous Associates Medical Group
- Retina Consultants San Diego
- Danbury Eye Physicians & Surgeons, P.C.
- Retina Group of Florida
- Central Florida Retina
- The University of Chicago
- Illinois Retina Associates, S.C.
- Midwest Eye Institute
- University of Kentucky, The Kentucky Clinic
- Maine Vitreoretinal Consultants
- National Retina Institute
- New England Eye Center
- Kresge Eye Institute/Hutzel Hospital
- Retina Associates
- Retina Associates of NJ
- Retina Associates of NJ
- Retina Associates of NJ
- NY Eye and Ear Infirmary
- Carolina Eye Associates
- Retina Associates of Cleveland
- Retina Assocites of Cleveland, Inc.
- Cleveland Clinical Foundation
- Retina Associates of Cleveland
- Retina Associates of Cleveland
- Retina Associates of Cleveland
- Scheie Eye Institute
- Austin Retina
- Vitreoretinal Consultants
- Wagner Mandell Retina Center
- Wagner Mandell Retina Center
- Medical College of Wisconsin/The Eye Institute