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

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.

Detailed Description

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Conditions

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Macular Edema, Cystoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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denufosol tetrasodium (INS37217) Intravitreal Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have persistent post cataract extraction macular edema whose condition is stable
* 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 proliferative vitreoretinopathy greater than grade B in either eye
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

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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