Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-03-13 @ 10:28 PM
Study NCT ID:
NCT02644694
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2015-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-04-05', 'releaseDate': '2019-01-10'}, {'resetDate': '2020-02-04', 'releaseDate': '2020-01-27'}], 'estimatedResultsFirstSubmitDate': '2019-01-10'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-12-30', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of dexamethasone', 'timeFrame': 'Day 1', 'description': 'Vitreous humor samples will be analyzed for dexamethasone concentrations'}, {'measure': 'Concentration of dexamethasone phosphate', 'timeFrame': 'Day 1', 'description': 'Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vitrectomy']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 85 years\n2. Receive, understand, and sign a copy of the written informed consent form\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02644694', 'briefTitle': 'PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyegate Pharmaceuticals, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EGP-437-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexamethasone Phosphate Ophthalmic Solution', 'description': 'Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System', 'interventionNames': ['Drug: Dexamethasone Phosphate Ophthalmic Solution']}], 'interventions': [{'name': 'Dexamethasone Phosphate Ophthalmic Solution', 'type': 'DRUG', 'description': 'Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System', 'armGroupLabels': ['Dexamethasone Phosphate Ophthalmic Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Jeffrey Heier, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Study Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyegate Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-10', 'type': 'RELEASE'}, {'date': '2019-04-05', 'type': 'RESET'}, {'date': '2020-01-27', 'type': 'RELEASE'}, {'date': '2020-02-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Eyegate Pharmaceuticals, Inc.'}}}}