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

Phase 1

Completed

• Conditions: Vitrectomy
• Interventions: Drug: Dexamethasone Phosphate Ophthalmic Solution

• Registration Number: NCT02644694
• Lead Sponsor: Eyegate Pharmaceuticals, Inc.

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Study Start: 2016-03
• Status Verified: 2016-06
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Concentration of dexamethasone	Day 1	Vitreous humor samples will be analyzed for dexamethasone concentrations
Concentration of dexamethasone phosphate	Day 1	Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations

Trial Locations

Locations (1)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States