Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 9:35 PM
Study NCT ID:
NCT05289661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2022-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descemet Endothelial Thickness Comparison Trial I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584679', 'term': 'K-115'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best spectacle-corrected visual acuity (BSCVA)', 'timeFrame': '12 months', 'description': 'Best spectacle-corrected visual acuity'}, {'measure': 'Endothelial cell loss', 'timeFrame': '12 months', 'description': 'Change between endothelial density at baseline versus density at 12 months'}], 'secondaryOutcomes': [{'measure': 'Best spectacle-corrected visual acuity (BSCVA)', 'timeFrame': '3, 6 and 24 months', 'description': 'Best spectacle-corrected visual acuity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fuchs']}, 'descriptionModule': {'briefSummary': 'Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata\n* Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)\n* Dysfunctional endothelium from prior graft failure after PKP or EK\n* Controlled uveitis (defined as quiet for \\> 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis\n* Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP \\< 5 mmHg) or no glaucoma\n* Good candidate for corneal transplantation for either DMEK or UT-DSAEK\n* Willingness to participate\n* Age greater than 18 years\n\nExclusion Criteria:\n\n* Aphakia, or anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK\n* Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment\n* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours\n* Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05289661', 'acronym': 'DETECT I', 'briefTitle': 'Descemet Endothelial Thickness Comparison Trial I', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Descemet Endothelial Thickness Comparison Trials (DETECT I & II)', 'orgStudyIdInfo': {'id': '20220590-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UT-DSAEK plus topical ripasudil', 'description': 'This arm will receive UT-DSAEK plus topical ripasudil 0.4%', 'interventionNames': ['Drug: Topical Ripasudil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'UT-DSAEK plus topical placebo', 'description': 'This arm will receive UT-DSAEK plus topical placebo', 'interventionNames': ['Drug: Topical Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DMEK plus topical ripasudil', 'description': 'This arm will receive DMEK plus topical ripasudil 0.4%', 'interventionNames': ['Drug: Topical Ripasudil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'DMEK plus topical placebo', 'description': 'This arm will receive DMEK plus topical placebo', 'interventionNames': ['Drug: Topical Placebo']}], 'interventions': [{'name': 'Topical Ripasudil', 'type': 'DRUG', 'otherNames': ['Ripasudil'], 'description': 'To determine the effect of rho-kinase inhibitors on endothelial cell loss', 'armGroupLabels': ['DMEK plus topical ripasudil', 'UT-DSAEK plus topical ripasudil']}, {'name': 'Topical Placebo', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'topical Placebo', 'armGroupLabels': ['DMEK plus topical placebo', 'UT-DSAEK plus topical placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33418', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jennifer Rose-Nussbaumer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'University of Miami', 'class': 'OTHER'}, {'name': 'Wills Eye Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer Rose-Nussbaumer', 'investigatorAffiliation': 'Stanford University'}}}}