PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy

Overview

The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Full Title of Study: “A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole Repair or Epiretinal Membrane Peeling”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

Detailed Description

This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Interventions

  • Drug: Dexamethasone Phosphate Ophthalmic Solution
    • Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System

Arms, Groups and Cohorts

  • Experimental: Dexamethasone Phosphate Ophthalmic Solution
    • Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System

Clinical Trial Outcome Measures

Primary Measures

  • Concentration of dexamethasone
    • Time Frame: Day 1
    • Vitreous humor samples will be analyzed for dexamethasone concentrations
  • Concentration of dexamethasone phosphate
    • Time Frame: Day 1
    • Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18 to 85 years 2. Receive, understand, and sign a copy of the written informed consent form Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eyegate Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeffrey Heier, M.D., Principal Investigator, Study Principal Investigator

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