Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Retinal Detachment

Intervention / Treatment
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* Drug: denufosol tetrasodium (INS37217) Intravitreal Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: denufosol tetrasodium (INS37217) Intravitreal Injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhegmatogenous retinal detachment, detached retina, retinal tear, retinal break