A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
NCT ID: NCT00135655
Last Updated: 2013-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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denufosol tetrasodium (INS37217) Intravitreal Injection
Eligibility Criteria
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Inclusion Criteria
* Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization
* Have at least one eligible eye to be treated in the study
* Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye
* Have macular edema confirmed by fluorescein angiography
Exclusion Criteria
* Have ocular disorders in the study eye that may confound interpretation of study results
* Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation
* Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
* Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma
* Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months
* Have had any ocular implant device for the delivery of therapeutic agents
* Be taking any excluded medications that could obscure or confound study results
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Principal Investigators
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Amy Schaberg, BSN
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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06-104
Identifier Type: -
Identifier Source: org_study_id
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