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NCT02644694 Clinical Trial

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

Vitrectomy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02644694
Other study ID # EGP-437-010
Secondary ID
Status Completed
Phase Phase 1
First received December 22, 2015
Last updated February 6, 2017
Start date March 2016
Est. completion date November 2016

Study information
Verified date June 2016
Source Eyegate Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date November 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Ophthalmic Consultants of Boston Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Concentration of dexamethasone Vitreous humor samples will be analyzed for dexamethasone concentrations Day 1
Primary Concentration of dexamethasone phosphate Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations Day 1
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Completed NCT03701542 - The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.
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