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
Verified date | June 2016 |
Source | Eyegate Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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: |
Country | Name | City | State |
---|---|---|---|
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Eyegate Pharmaceuticals, Inc. |
United States,
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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