- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114062
Study to Treat Uveitis Associated Macular Edema
November 28, 2016 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 Uveitis Associated Macular Edema
The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME.
Denufosol tetrasodium may also reverse the fluid accumulation of UME.
Study Type
Interventional
Enrollment (Actual)
15
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 anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- Have persistent macular edema and uveitis whose conditions are stable
- Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)
- Have an OCT scan with a qualifying retinal thickness in the study eye
- Have evidence of macular edema on OCT scan
- Have at lease one eligible eye to be treated in the study based on visual acuity.
Exclusion Criteria:
- Have proliferative vitreoretinopathy greater than grade B
- Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA
- Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye
- Have ocular disorders in the study eye that may confound interpretation of study results
- Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
- Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye
- Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening
- Have any ocular implant device for the delivery of therapeutic agents to the eye
- 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 |
---|
Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema.
|
Assess the utility of denufosol in treating uveitis associated macular edema.
|
Secondary Outcome Measures
Outcome Measure |
---|
Pilot study - not specified
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2005
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
June 13, 2005
First Submitted That Met QC Criteria
June 13, 2005
First Posted (Estimate)
June 14, 2005
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-103
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.
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Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
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CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
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EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
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Merck Sharp & Dohme LLCCystic Fibrosis FoundationCompleted
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Merck Sharp & Dohme LLCCompleted
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Merck Sharp & Dohme LLCCompleted
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Merck Sharp & Dohme LLCTerminated