A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
May 20, 2013 updated by: Merck Sharp & Dohme LLC
A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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safety
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tolerability
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visual acuity
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retinal thickness
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amy Schaberg, BSN, Merck Sharp & Dohme LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Study Registration Dates
First Submitted
August 24, 2005
First Submitted That Met QC Criteria
August 24, 2005
First Posted (Estimate)
August 26, 2005
Study Record Updates
Last Update Posted (Estimate)
May 21, 2013
Last Update Submitted That Met QC Criteria
May 20, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.