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

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.

Study Overview

• Status: Completed
• Conditions: Uveitis, Anterior
• Intervention / Treatment: Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System; Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System; Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System; Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Narayana Nethralaya
    • Bangalore, Karnataka, India, 560 037
      • St. Johns Medical College And Hospital
    • Bangalore, Karnataka, India, 560 037
      • Vittala International Institute of Ophthalmology
    • Hubli, Karnataka, India, 580 021
      • M. M. Joshi Eye Institute
    • Manipal, Karnataka, India, 576104
      • Kasturba Medical College and Hospital
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632011
      • Christian Medical College
• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Eye Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Cambridge, Massachusetts, United States, 02142
      • Massachusetts Eye Research and Surgery Institution
  • Missouri
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care Ltd.
  • New York
    • New York, New York, United States, 10003
      • New York Eye & Ear Infirmary
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Eye Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Services University
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Pennsylvania College of Optometry
    • Philadelphia, Pennsylvania, United States, 19104
      • Scheie Eye Institue
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Southern College of Optometry
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-infectious anterior uveitis

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EGP-437 1.6 mA-min at 0.4 mA; Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA	Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System; Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System; Other Names: Dexamethasone Phosphate Ophthalmic Solution
Active Comparator: EGP-437 4.8 mA-min at 1.2 mA; Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA	Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System; Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System; Other Names: Dexamethasone Phosphate Ophthalmic Solution
Active Comparator: EGP-437 10.0 mA-min at 2.5 mA; Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA	Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System; Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System; Other Names: Dexamethasone Phosphate Ophthalmic Solution
Active Comparator: EGP-437 14.0 mA-min at 3.5 mA; Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA	Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System; Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System; Other Names: Dexamethasone Phosphate Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Prospective study, subjects followed for 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ACC score of zero	Time to anterior chamber cell score of zero	Prospective study, subjects followed for 28 days
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	Prospective study, subjects followed for 28 days
Change from baseline in ACC score at Day 28	Change from baseline in anterior chamber cell score at Day 28	Prospective study, subjects followed for 28 days
Treatment emergent adverse events	Treatment emergent adverse events	Prospective study, subjects followed for 28 days

Collaborators and Investigators

• Sponsor: Eyegate Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Michael Raizman, MD, Ophthalmic Consultants of Boston; Principal Investigator: C. Stephen Foster, MD, Massachusetts Eye Research and Surgery Institution

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 5, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 10, 2008

Study Record Updates

• Last Update Posted (Estimate): August 31, 2010
• Last Update Submitted That Met QC Criteria: August 27, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Ophthalmology; Iontophoresis; Non-Infectious Acute Anterior Segment Uveitis
• Additional Relevant MeSH Terms: Eye Diseases; Panuveitis; Uveal Diseases; Uveitis; Uveitis, Anterior; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Ophthalmic Solutions; Pharmaceutical Solutions; Dexamethasone 21-phosphate
• Other Study ID Numbers: EGP-437-001