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

Eyegate Pharmaceuticals, Inc.10 enrolled

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vitrectomy

Interventions

Dexamethasone Phosphate Ophthalmic SolutionDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Concentration of dexamethasone

Vitreous humor samples will be analyzed for dexamethasone concentrations

Time frame: Day 1

Concentration of dexamethasone phosphate

Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations

Time frame: Day 1

Data from ClinicalTrials.gov

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