Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
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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.
A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Rhegmatogenous Retinal Detachment
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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