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Anterior UveitisPhase 3NCT01505088

Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis

A Phase 3 study testing 40 mg/mL Dexamethasone phosphate ophthalmic solution, Prednisolone Acetate (1%) Eyedrops and 100 mM sodium citrate buffer solution in people with Anterior Uveitis, run by Eyegate Pharmaceuticals, Inc. at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis. Read more about this study

Who is it for?
Ages 12 to 85 years
Conditions the study is for
Anterior Uveitis
What is being tested?
40 mg/mL Dexamethasone phosphate ophthalmic solution, Prednisolone Acetate (1%) Eyedrops and 100 mM sodium citrate buffer solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
193 participants
Where
39 sitesUnited States
Study dates
Dec 2011to Mar 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber cell count of ≥ 11 cells
  • 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

Who cannot join

  • Have uveitis of infectious etiology
  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Emory Eye Center

    Atlanta, Georgia, 30322

  • Austin Retina Associates

    Austin, Texas, 78705

  • Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Department of Ophthalmology at University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • The Eye Associates of Manatee, LLP

    Bradenton, Florida, 34209

  • Connecticut Retina Consultants, LLC

    Bridgeport, Connecticut, 06606

  • Massachusetts Eye Research and Surgery Institution

    Cambridge, Massachusetts, 02142

  • Arizona Eye Center

    Chandler, Arizona, 85225

  • Lifelong Vision Foundation

    Chesterfield, Missouri, 63017

  • Illinois Retina Associates

    Chicago, Illinois, 60612

  • Ellsworth Uveitis and Retina Care

    Ellsworth, Maine, 04605

  • Advanced Eye Care

    Fort Oglethorpe, Georgia, 30742

  • Colorado Retina Associates

    Golden, Colorado, 80401

  • Eye Center of Southern Connecticut

    Hamden, Connecticut, 06518

  • Houston Eye Associates

    Houston, Texas, 77025

  • Raj K. Maturi, M.D. PC

    Indianapolis, Indiana, 46290

  • Levenson Eye Associates

    Jacksonville, Florida, 32204

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • Corneal Consultants of Colorado

    Littleton, Colorado, 80120

  • Doheny Eye Medical Group

    Los Angeles, California, 90033

  • Charlotte Eye Ear Nose and Throat Associates

    Matthews, North Carolina, 28105

  • Southern College of Optometry

    Memphis, Tennessee, 38104

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Yale Eye Center

    New Haven, Connecticut, 06510

  • The New York Eye and Ear Infirmary

    New York, New York, 10003

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • Metropolitan Eye Research and Surgery Institute

    Palisades Park, New Jersey, 07650

  • Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Mid-Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • Logan Ophthalmic Research

    Tamarac, Florida, 33321

  • Comprehensive Eye Care Ltd.

    Washington, Missouri, 63090

Other trials in United States

About this study

Official title: A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Read the detailed description

Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it is the most common form of uveitis and accounts for approximately 75% of cases.

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.

Being tested
40 mg/mL Dexamethasone phosphate ophthalmic solution, Prednisolone Acetate (1%) Eyedrops, 100 mM sodium citrate buffer solution, Placebo Eyedrops
Keywords
Iontophoresis, Non-Infectious Anterior Segment Uveitis, Ophthalmology
Medical subject headings
Uveitis, Anterior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 40 mg/mL Dexamethasone phosphate ophthalmic solutionDrug

    Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)

  • Prednisolone Acetate (1%) EyedropsDrug

    Prednisolone acetate (1%) eyedrops

  • 100 mM sodium citrate buffer solutionDrug

    Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution

  • Placebo EyedropsDrug

    Also called Saline/ Benzalkonium Chloride (BAK) Ophthalmic Solution

    Placebo Eyedrops

Study groups in NCT01505088
Study groupRoleWhat they receive
Iontophoretic Dexamethasone Phosphate Ophthalmic SolutionExperimentalDexamethasone 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.
Receives: Drug: 40 mg/mL Dexamethasone phosphate ophthalmic solution; Drug: Placebo Eyedrops
Prednisolone Acetate Ophthalmic Suspension (1%)Active comparatorPlacebo (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.
Receives: Drug: Prednisolone Acetate (1%) Eyedrops; Drug: 100 mM sodium citrate buffer solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with with ACC count of zero at Day 14

    Proportion of patients with ACC count of zero at Day 14

    Measured: At Day 14 (plus or minus two days) following the first study treatment

Secondary outcomes (12)

  1. Proportion of patients with ACC count of zero at Day 7

    Proportion of patients with ACC count of zero at Day 7

    Measured: At Day 7 (plus or minus two days) following the first study treatment

  2. Proportion of patients with ACC count of zero at Day 28

    Proportion of patients with ACC count of zero at Day 28

    Measured: At Day 28 (plus or minus two days) following the first study treatment

  3. Proportion of patients with ACC count of zero at Day 56

    The proportion of patients with ACC count of zero at Day 56

    Measured: At Day 56 (plus or minus seven days) following the first study treatment

  4. Mean change from baseline in ACC count and score at Day 7

    Mean change from baseline in ACC count and score at Day 7

    Measured: At Day 7 (plus or minus two days) following the first study treatment

  5. Mean change from baseline in ACC count and score at Day 14

    Mean change from baseline in ACC count and score at Day 14

    Measured: At Day 14 (plus or minus two days) following the first study treatment

  6. Mean change from baseline in ACC count and score at Day 28

    Mean change from baseline in ACC count and score at Day 28

    Measured: At Day 28 (plus or minus two days) following the first study treatment

  7. Mean change from baseline in ACC count and score at Day 56

    Mean change from baseline in ACC count and score at Day 56

    Measured: At Day 56 (plus or minus seven days) following the first study treatment

  8. Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7

    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7

    Measured: At Day 7 (plus or minus two days) following the first study treatment

  9. Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14

    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14

    Measured: At Day 14 (plus or minus two days) following the first study treatment

  10. Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28

    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28

    Measured: At Day 28 (plus or minus two days) following the first study treatment

  11. Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56

    Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56

    Measured: At Day 56 (plus or minus seven days) following the first study treatment

  12. Time to anterior chamber cell count and score of zero

    Time to anterior chamber cell count and score of zero

    Measured: Up to 56 days (plus or minus seven days) following the first study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionFeb 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01505088
Sponsor's protocol ID
EGP-437-004
Status last verified
Mar 2013
First submitted
4 Jan 2012
Last updated
29 Mar 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 40 mg/mL Dexamethasone phosphate ophthalmic solution, Prednisolone Acetate (1%) Eyedrops and 100 mM sodium citrate buffer solution in people with Anterior Uveitis, run by Eyegate Pharmaceuticals, Inc. at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with with ACC count of zero at Day 14 (time frame: At Day 14 (plus or minus two days) following the first study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01505088.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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