Status:
TERMINATED
Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Retinal Detachment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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
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 witho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00083967
Start Date
June 1 2004
End Date
April 1 2006
Last Update
April 10 2015
Active Locations (33)
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1
Retina Center, P.C.
Tucson, Arizona, United States, 85704
2
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
3
Retina Vitreous Associates Medical Group
Los Angeles, California, United States, 90017
4
Retina Consultants San Diego
Poway, California, United States, 92064