Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
NCT ID: NCT01505088
Last Updated: 2013-03-29
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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COMPLETED
PHASE3
193 participants
INTERVENTIONAL
2011-12-31
2013-03-31
Brief Summary
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Detailed Description
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In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437 treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without requiring additional treatment; produced low short-term systemic exposure to dexamethasone and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8 mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid mediated effects were observed.
The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Iontophoretic Dexamethasone Phosphate Ophthalmic Solution
Dexamethasone phosphate (40 mg/mL) solution delivered by iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying placebo eyedrops (saline solution) for up to 28 days.
40 mg/mL Dexamethasone phosphate ophthalmic solution
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Placebo Eyedrops
Placebo Eyedrops
Prednisolone Acetate Ophthalmic Suspension (1%)
Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying prednisolone acetate ophthalmic suspension (1%) (positive control) eyedrops for up to 28 days.
Prednisolone Acetate (1%) Eyedrops
Prednisolone acetate (1%) eyedrops
100 mM sodium citrate buffer solution
Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution
Interventions
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40 mg/mL Dexamethasone phosphate ophthalmic solution
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Prednisolone Acetate (1%) Eyedrops
Prednisolone acetate (1%) eyedrops
100 mM sodium citrate buffer solution
Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution
Placebo Eyedrops
Placebo Eyedrops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receive, understand, and sign a copy of the written informed consent form
* Be able to return for all study visits and willing to comply with all study-related instructions
Exclusion Criteria
* Have active intermediate or posterior uveitis
* Known positive HLA-B27 with a severe (4+) fibrinoid reaction
* Have previous anterior segment uveitis episode in the study eye ≤ 4 weeks prior to baseline visit
* Have used topical corticosteroid treatment in the study eye ≤ 48 hours prior to baseline visit
* Have used oral corticosteroid within the past 14 days prior to baseline
* Have received intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months prior to baseline visit
* Currently using prescribed nonsteroidal anti-inflammatory agents (i.e., use of over-the-counter dosages is allowable) or prescribed immunosuppressive agents, unless the dose has been stable for the last six weeks and no change in dosing is anticipated for the duration of the study
* Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications in the study eye
* Be known steroid intraocular pressure responders in either eye
* Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
* Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
* Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
* Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin, or Behçet's disease
* Have monocular or BCVA worse than 20/80 in the fellow eye
* Have optic neuritis of any origin
* Have clinically suspected or confirmed central nervous system or ocular lymphoma
* Planning to undergo elective ocular surgery during the study
* Have active hyphema, pars planitis, choroiditis, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
* Have severe/serious ocular pathology or medical condition which may preclude study completion
* Have pacemaker and/or any other electrical sensitive support system
* Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
* Have participated in another investigational device or drug study within 30 days of baseline visit
* Have significant Fuch's Corneal Dystrophy
12 Years
85 Years
ALL
No
Sponsors
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Eyegate Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John D. Sheppard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Virginia Eye Consultants
Locations
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Department of Ophthalmology at University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Eye Center
Chandler, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Doheny Eye Medical Group
Los Angeles, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Corneal Consultants of Colorado
Littleton, Colorado, United States
Connecticut Retina Consultants, LLC
Bridgeport, Connecticut, United States
Eye Center of Southern Connecticut
Hamden, Connecticut, United States
Yale Eye Center
New Haven, Connecticut, United States
The Eye Associates of Manatee, LLP
Bradenton, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Logan Ophthalmic Research
Tamarac, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
Advanced Eye Care
Fort Oglethorpe, Georgia, United States
Illinois Retina Associates
Chicago, Illinois, United States
Raj K. Maturi, M.D. PC
Indianapolis, Indiana, United States
Ellsworth Uveitis and Retina Care
Ellsworth, Maine, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Massachusetts Eye Research and Surgery Institution
Cambridge, Massachusetts, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Tauber Eye Center
Kansas City, Missouri, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, United States
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States
The New York Eye and Ear Infirmary
New York, New York, United States
Charlotte Eye Ear Nose and Throat Associates
Matthews, North Carolina, United States
Casey Eye Institute
Portland, Oregon, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Mid-Atlantic Retina
Philadelphia, Pennsylvania, United States
Southern College of Optometry
Memphis, Tennessee, United States
Austin Retina Associates
Austin, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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Other Identifiers
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EGP-437-004
Identifier Type: -
Identifier Source: org_study_id