Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02834260
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007640', 'term': 'Keratoconus'}, {'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}, {'id': 'C566452', 'term': 'Corneal Dystrophy, Congenital Stromal'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraocular pressure', 'timeFrame': 'one month post graft'}], 'secondaryOutcomes': [{'measure': 'Score of ocular discomfort', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12', 'description': 'analogic visual scale'}, {'measure': 'Ocular redness', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12', 'description': 'digital picture'}, {'measure': 'Rejection episodes', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12'}, {'measure': 'Graft thickness', 'timeFrame': 'one month post graft'}, {'measure': 'Patient requiring dexamethasone eyedrops', 'timeFrame': 'one month post graft'}, {'measure': 'Date of disappearance of the implant', 'timeFrame': 'up to 1 year'}, {'measure': 'intraocular pressure', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12'}, {'measure': 'presence of hemorrhage', 'timeFrame': 'Day 1, Day 2, Day 3, Day 4, Day 5, Day 15, Month 1, Week 5, Week 6, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12', 'description': 'with tomography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['absorbable implant', 'subconjunctival', 'immune rejection', 'safety profile', 'dexamethasone'], 'conditions': ['Keratoconus', "Fuchs' Endothelial Dystrophy", 'Congenital Hereditary Stromal Dystrophy of the Cornea']}, 'referencesModule': {'references': [{'pmid': '34426402', 'type': 'DERIVED', 'citation': 'Trone MC, Poinard S, Crouzet E, Garcin T, Mentek M, Forest F, Matray M, Thuret G, Gain P. Dropless penetrating keratoplasty using a subconjunctival dexamethasone implant: safety pilot study. Br J Ophthalmol. 2023 Feb;107(2):181-186. doi: 10.1136/bjophthalmol-2021-319376. Epub 2021 Aug 23.'}]}, 'descriptionModule': {'briefSummary': 'Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. They mainly occur during the first 18 months. Prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. Eye drops are instilled three times a day during at least 3 months then tapered.\n\nOZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. It is indicated for intravitreal injection to treat macular edema.\n\nThe investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Keratoconus\n* Fuch's dystrophy\n* Hereditary stromal dystrophy\n* Age 18 years old and more\n* Signed informed consent\n* Affiliated to the French Social Security\n\nExclusion Criteria:\n\n* Hypersensitivity to Dexamethasone or the excipients (polylactic and glycolic acid)\n* Active ocular or periocular infection\n* Advanced glaucoma\n* History of herpetic or zoster keratitis\n* Retinal disease for which an intravitreal injection of Ozurdex is planed for the next 3-4 months"}, 'identificationModule': {'nctId': 'NCT02834260', 'acronym': 'IDEXACOR', 'briefTitle': 'Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone: Tolerance and Safety Pilot Study', 'orgStudyIdInfo': {'id': '1608042'}, 'secondaryIdInfos': [{'id': '2016-001168-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ozurdex group', 'description': "Subconjunctival injection of the absorbable implant of Dexamethasone immediately at the end of penetrating keratoplasty. The injection is made at the 12 O'Clock position is a bubble created by subconjunctival injection of balanced salt solution.", 'interventionNames': ['Drug: Dexamethasone implant OZURDEX']}], 'interventions': [{'name': 'Dexamethasone implant OZURDEX', 'type': 'DRUG', 'armGroupLabels': ['ozurdex group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Marie Caroline TRONE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}