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Sponsored by: |
Inspire Pharmaceuticals |
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Information provided by: | Inspire Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00083967 |
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.
Condition | Intervention | Phase |
---|---|---|
Retinal Detachment |
Drug: denufosol tetrasodium (INS37217) Intravitreal Injection |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 160 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | April 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Amy Schaberg, BSN | Unaffiliated |
Study ID Numbers: | 06-102 |
Study First Received: | June 3, 2004 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00083967 History of Changes |
Health Authority: | United States: Food and Drug Administration |
rhegmatogenous retinal detachment detached retina retinal tear retinal break |
Lacerations Retinal Detachment Eye Diseases Retinal Perforations Retinal Diseases |
Retinal Detachment Eye Diseases Retinal Diseases |