Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04752020
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2021-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}], 'ancestors': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in central corneal pachymetry over time', 'timeFrame': 'Measured at post-operative month one visit and then every 2 months for 1 year', 'description': 'Corneal thickness on clinical examination and corneal topography'}, {'measure': 'Change in endothelial cell count over time', 'timeFrame': 'Measured at post-operative month one visit and then every 2 months for 1 year', 'description': 'Central endothelial cell count by specular microscopy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Descemetorhexis without endothelial keratoplasty'], 'conditions': ["Fuchs' Endothelial Dystrophy"]}, 'referencesModule': {'references': [{'pmid': '38780446', 'type': 'DERIVED', 'citation': 'Bal S, Pineda R, Davies E. Prospective Assessment of Adjuvant Netarsudil Use in Patients Undergoing Descemet Stripping Only. Cornea. 2025 Mar 1;44(3):286-290. doi: 10.1097/ICO.0000000000003578. Epub 2024 May 23.'}]}, 'descriptionModule': {'briefSummary': 'This will be a prospective assessment of whether adjuvant Netarsudil use in patients undergoing Descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. The anticipated enrollment is 25 patients.', 'detailedDescription': 'Subjects meeting inclusion criteria will be identified by Massachusetts Eye and Ear cornea surgeons during their pre-operative assessment and invited to participate in the study. Written informed consent will be obtained from the patient. The patients will then be added to a shared Epic patient list with a shared to-do column (outside of the patient record) indicating their subject ID and date of recruitment. All subjects will be asked to provide their best contact phone number which will be updated in the chart.\n\nUpon obtaining informed consent, subjects will receive a bottle of Netarsudil from the Massachusetts Eye and Ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . Each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. Clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. Corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes.\n\nA retrospective chart review will be performed prior to new patient enrollment for patients who had previously had DWEK and did not receive a rho-kinase inhibitor. These patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fuchs corneal dystrophy\n\nExclusion Criteria:\n\n* Women of childbearing potential\n* Other corneal eye diseases\n* Non-compliance with netarsudil\n* Intolerance of netarsudil'}, 'identificationModule': {'nctId': 'NCT04752020', 'briefTitle': 'Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts Eye and Ear Infirmary'}, 'officialTitle': 'Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty', 'orgStudyIdInfo': {'id': '2020P002755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Netarsudil use', 'description': 'Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance', 'interventionNames': ['Drug: Netarsudil Ophthalmic']}], 'interventions': [{'name': 'Netarsudil Ophthalmic', 'type': 'DRUG', 'description': 'Use of netarsudil after Descemetorhexis without endothelial keratoplasty', 'armGroupLabels': ['Netarsudil use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02127', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts Eye and Ear Infirmary', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Emma Davies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear Infirmary'}, {'name': 'Sila E Bal, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts Eye and Ear Infirmary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts Eye and Ear Infirmary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Emma C. Davies, MD', 'investigatorAffiliation': 'Massachusetts Eye and Ear Infirmary'}}}}