EGP Uveitis Trial

Active Clinical Trials // Feb 14 2017

sponsored by Privately Funded Source

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.

Principal Investigator: Neal Barney

Study Coordinator: Chris Smith

Study Objective

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.

Study Design

This is a prospective, multi-center, randomized, double-masked Phase 3 non-inferiority clinical trial designed to evaluate whether the study treatment (EGP-437) is non-inferior to the control treatment [prednisolone acetate ophthalmic suspension (1%)] to within a 10% margin in patients with non-infectious anterior segment uveitis.

Major Eligibility Criteria

Subjects must meet all of the following requirements to be eligible for enrollment into the study:

  1. Age 12 to 85 years with a diagnosis of non-infectious anterior

segment uveitis defined as an anterior chamber (AC) cell count of ≥ 11 cells

  1. Receive, understand, and sign a copy of the written informed

consent form (ICF)

  1. Be able to return for all study visits and willing to comply with

all study-related instructions

Exclusion Criteria

Subjects may not participate in the study if any of the following

criteria are met:

  1. Have uveitis of infectious etiology
  2. Have active intermediate or posterior uveitis
  3. Have known positive HLA-B27 with a severe (4+)

fibrinoid reaction

  1. Have previous anterior segment uveitis episode in the

study eye ≤ 4 weeks prior to the baseline visit (Day 0)

  1. Have used topical corticosteroid treatment in the study

eye ≤ 48 hours prior to the baseline visit (Day 0)

  1. Have used oral corticosteroid within the past 14 days

prior to the baseline visit. [Subjects using inhaled

corticosteroids are eligible as long as they have been

on a stable dose of the inhalant for 30 days prior to

the baseline visit (Day 0).]

  1. Have received intravitreal or sub-Tenon corticosteroid

treatment in the study eye within the 3 months prior to the

baseline visit (Day 0) or have received Ozurdex® (Allergan)

in the study eye within the 6 months prior to the baseline visit

(Day 0)

  1. Are currently using prescribed nonsteroidal antiinflammatory

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

  1. Have IOP ≥ 25 mmHg at baseline, a history of

glaucoma, or require ocular anti-hypertensive

medications in the study eye

  1. Are known steroid intraocular pressure responders in either

eye

  1. Have open wounds/skin disease on the forehead area where

the iontophoresis return electrode will be applied

  1. Have severe lesions of the eyelids or the ocular surface

impeding the application of the iontophoresis applicator

  1. Have known allergy to dexamethasone or dexamethasone

phosphate or any medication to be used in this study

  1. Have a history or diagnosis of ocular herpes, corneal lesion

of suspected herpetic origin, or Behçet’s disease

  1. Are monocular or have BCVA worse than 20/80 in the

fellow eye

  1. Have optic neuritis of any origin
  2. Have diagnosed Fuchs’ heterochromic iridocyclitis
  3. Have clinically suspected or confirmed central nervous

system or ocular lymphoma

  1. Have undergone ocular surgery within 2 weeks prior to the

baseline visit (Day 0) or are planning to undergo elective

ocular surgery during the study

  1. Have active hyphema, pars planitis, choroiditis, clinically

significant macular edema (CSME), toxoplasmosis scar, or

vitreous hemorrhage. CSME findings on ophthalmoscopy

at the slit lamp include: (1) Retinal thickening within 500

μm of the center of the fovea; (2) Hard, yellow exudates

within 500 μm of the center of the fovea with adjacent

retinal thickening; (3) At least one disc area of retinal

thickening, with any part within one disc diameter of the

center of the fovea.

  1. Have severe/serious ocular pathology or medical condition

which may preclude study completion

  1. Have a pacemaker and/or any other electrically sensitive

support system

  1. Are pregnant or lactating female, or female of childbearing

age and using inadequate birth control method

  1. Have participated in another investigational device or drug

study within 30 days of the baseline visit (Day 0)

  1. Have participated in EyeGate’s EGP-437-004 clinical trial

for uveitis

For more information please contact Chris Smith at 608-263-7169