A Study of the Safety and Effectiveness of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution for Non-Infectious Anterior Uveitis

Overview

About this study

The purpose of this study is to compare the safety and effectiveness of ocular (eye) iontophoresis with dexamethasone phosphate eye drops (EGP-437) versus prednisolone acetate (1%) eye drops in patients with a non-infectious inflammation inside the eye.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age 12 to 85 years 
  • Has a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells per high power field 
  • Has received, understood, and signed a copy of the written informed consent form 
  • Is able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria 

  • Has uveitis of infectious etiology
  • Has active intermediate or posterior uveitis
  • Has hypopyon
  • Has known positive HLA-B27 with a severe (4+) fibrinoid reaction
  • Has previous anterior segment uveitis episode in the study eye ≤ 4 weeks prior to the baseline visit (day 0)
  • Has used topical corticosteroid treatment in the study eye within the 48 hours prior to the visit 1 assessments
  • Has used oral corticosteroid within the past 14 days prior to the baseline visit. 
    • Inhaled corticosteroids and dermal corticosteroid ointments are eligible as long as there has been a stable dose for 30 days prior to the baseline visit (day 0)
  • Has received intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 3 months prior to baseline visit (day 0)
  • Has received Ozurdex® (Allergan) in the study eye within the past 6 months prior to the baseline visit (day 0)
  • Is currently using prescribed non-steroidal 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
  • Has IOP ≥ 25 mmHg at baseline, a history of glaucoma, or requires ocular anti-hypertensive medications in the study eye
  • Is a  known steroid intraocular pressure responder in either eye
  • Has open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
  • Has severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
  • Has known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
  • Has a history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin, or Behçet’s disease
  • Is monocular or has BCVA worse than 20/80 in the fellow eye
  • Has diagnosed Fuchs’ heterochromic iridocyclitis
  • Has optic neuritis of any origin
  • Has clinically suspected or confirmed central nervous system or ocular lymphoma
  • Has undergone ocular surgery in the study eye within 2 weeks prior to the baseline visit (day 0) or is planning to undergo elective ocular surgery during the study
  • Has active hyphema, pars planitis, choroiditis, clinically significant macular edema (CSME), toxoplasmosis scar, or vitreous hemorrhage 
    • CSME, as defined by the ETDRS, exists with any of the following findings upon contact lens biomicroscopic ophthalmoscopy at the slit lamp
      • Retinal thickening within 500 μm of the center of the fovea
      • Hard, yellow exudates within 500 μm of the center of the fovea with adjacent retinal thickening 
      • At least one disc area of retinal thickening, with any part within one disc diameter of the center of the fovea
  • Has severe/serious ocular pathology or medical condition which may preclude study completion
  • Has pacemaker and/or any other electrically sensitive support system
  • Is pregnant or lactating, or of childbearing age and using inadequate birth control method
  • Has participated in another investigational device or drug study within 30 days of the baseline visit (day 0)
  • Has participated in EyeGate’s EGP-437-004 clinical trial for uveitis

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Wendy Smith, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20260177

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