Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07024693
Status:
RECRUITING
Last Update Posted:
2025-06-22
First Post:
2025-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FECD Biomarkers: Splicing Panel', 'timeFrame': 'Perioperative', 'description': 'Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'Through study completion, an average of 4 weeks.', 'description': 'Frequency of treatment-emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fuchs Endothelial Corneal Dystrophy', 'Fuchs']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.designtx.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.\n* ≥30 years of age (inclusive).\n* Documented diagnosis of FECD in the study eligible eye.\n* Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation.\n* Any clinically significant medical, nonmedical, and psychiatric disorders that could put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.\n* Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.\n* Concurrent or anticipated use of topical corticosteroids in the study eye.\n* Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.\n* Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.\n* Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.\n* Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.\n* Female participant is pregnant, planning a pregnancy, or breast-feeding.\n* Participant is unwilling to comply with the contraceptive requirements, as per protocol."}, 'identificationModule': {'nctId': 'NCT07024693', 'briefTitle': 'DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Design Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty', 'orgStudyIdInfo': {'id': 'DTX-168-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Drug: DT-168', 'interventionNames': ['Drug: DT-168']}], 'interventions': [{'name': 'DT-168', 'type': 'DRUG', 'description': 'Active', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'DTX-168-201 Study Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'DTX-168-201 Study Site', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'centralContacts': [{'name': 'Mark Daniels', 'role': 'CONTACT', 'email': 'mark@designtx.com', 'phone': '858-293-4948'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Design Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}