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

EyeGate Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Vitrectomy

Treatments: Drug: Dexamethasone Phosphate Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02644694

EGP-437-010

Details and patient eligibility

About

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 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Dexamethasone Phosphate Ophthalmic Solution

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone Phosphate Ophthalmic Solution