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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution | Experimental | Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Phosphate Ophthalmic Solution | Drug | Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of dexamethasone | Vitreous humor samples will be analyzed for dexamethasone concentrations | Day 1 |
| Concentration of dexamethasone phosphate | Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Heier, M.D. | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 10, 2019 | |
| Reset | Apr 5, 2019 | |
| Release | Jan 27, 2020 | |
| Reset | Feb 4, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 10, 2019 | Apr 5, 2019 | |||
| Jan 27, 2020 |
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| Feb 4, 2020 |