Study of Denufosol (INS37217) in Subjects 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

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.

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