AzTrials
AzTrials

Uveitis, AnteriorPhase 2NCT00694135

Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

A Phase 2 study testing EGP-437 1.6 mA-min at 0.4 with EyeGate® II System, EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System and EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System in people with Uveitis, Anterior, run by Eyegate Pharmaceuticals, Inc. at 19 sites in 2 countries.

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 define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System 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
Uveitis, Anterior
What is being tested?
EGP-437 1.6 mA-min at 0.4 with EyeGate® II System, EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System and EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
19 sitesin 2 countries
Study dates
Jun 2008to Aug 2009
Phase
Phase 2
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

  • Non-infectious anterior uveitis

Who cannot join

  • Uveitis of infectious etiology
  • Previous anterior uveitis episode ≤ 4 weeks prior to baseline
  • Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
  • Topical corticosteroid treatment in either eye < 48 hours prior to baseline
  • Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline
  • Active intermediate or posterior uveitis

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States13 sites

  • Emory Eye Center

    Atlanta, Georgia, 30322

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Massachusetts Eye Research and Surgery Institution

    Cambridge, Massachusetts, 02142

  • Cleveland Eye Clinic

    Cleveland, Ohio, 44195

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Pennsylvania College of Optometry

    Elkins Park, Pennsylvania, 19027

  • Southern College of Optometry

    Memphis, Tennessee, 38104

  • University of Miami

    Miami, Florida, 33136

  • New York Eye & Ear Infirmary

    New York, New York, 10003

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • Scheie Eye Institue

    Philadelphia, Pennsylvania, 19104

  • Oregon Health Services University

    Portland, Oregon, 97239

  • Comprehensive Eye Care Ltd.

    Washington, Missouri, 63090

Other trials in United States

India6 sites

  • St. Johns Medical College and Hospital

    Bangalore, Karnataka, 560 037

  • Vittala International Institute of Ophthalmology

    Bangalore, Karnataka, 560 037

  • Narayana Nethralaya

    Bangalore, Karnataka, 560010

  • M. M. Joshi Eye Institute

    Hubli, Karnataka, 580 021

  • Kasturba Medical College and Hospital

    Manipal, Karnataka, 576104

  • Christian Medical College

    Vellore, Tamil Nadu, 632011

Other trials in India

About this study

Official title: A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis

The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.

Read the detailed description

This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

Being tested
EGP-437 1.6 mA-min at 0.4 with EyeGate® II System, EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System, EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System, EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Keywords
Iontophoresis, Non-Infectious Acute 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.

  • EGP-437 1.6 mA-min at 0.4 with EyeGate® II SystemDrug

    Also called Dexamethasone Phosphate Ophthalmic Solution

    Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System

  • EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II SystemDrug

    Also called Dexamethasone Phosphate Ophthalmic Solution

    Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System

  • EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II SystemDrug

    Also called Dexamethasone Phosphate Ophthalmic Solution

    Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System

  • EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II SystemDrug

    Also called Dexamethasone Phosphate Ophthalmic Solution

    Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System

Study groups in NCT00694135
Study groupRoleWhat they receive
EGP-437 1.6 mA-min at 0.4 mAActive comparatorOcular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
Receives: Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
EGP-437 4.8 mA-min at 1.2 mAActive comparatorOcular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
Receives: Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
EGP-437 10.0 mA-min at 2.5 mAActive comparatorOcular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
Receives: Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
EGP-437 14.0 mA-min at 3.5 mAActive comparatorOcular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
Receives: Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System

What is being measured

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

  1. Proportion of subjects with an ACC score of zero at Days 14 and 28

    Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28

    Measured: Prospective study, subjects followed for 28 days

Secondary outcomes (4)

  1. Time to ACC score of zero

    Time to anterior chamber cell score of zero

    Measured: Prospective study, subjects followed for 28 days

  2. Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28

    Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28

    Measured: Prospective study, subjects followed for 28 days

  3. Change from baseline in ACC score at Day 28

    Change from baseline in anterior chamber cell score at Day 28

    Measured: Prospective study, subjects followed for 28 days

  4. Treatment emergent adverse events

    Treatment emergent adverse events

    Measured: Prospective study, subjects followed for 28 days

Timeline

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

  1. First posted10 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJul 2009
  4. Study completionAug 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00694135
Sponsor's protocol ID
EGP-437-001
Status last verified
Aug 2010
First submitted
5 Jun 2008
Last updated
31 Aug 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EGP-437 1.6 mA-min at 0.4 with EyeGate® II System, EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System and EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System in people with Uveitis, Anterior, run by Eyegate Pharmaceuticals, Inc. at 19 sites in 2 countries.

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 1 inclusion and 6 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 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 subjects with an ACC score of zero at Days 14 and 28 (time frame: Prospective study, subjects followed for 28 days). 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 NCT00694135.

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 31 Aug 2010.

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