Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Phase 2 Study To Determine the Safety and Efficacy of TTHX1114(NM141) on the Regeneration and Migration of Corneal Endothelial Cells in Patients Undergoing DWEK/DSO

ID
Name
TTHX-002
Description
Open label, single-treatment, with a concurrent non-treatment control
Trial arms
Trial start
2021-02-01
Estimated PCD
2022-11-16
Trial end
2023-01-13
Status
Completed
Phase
Early phase I
Treatment
TTHX1114(NM141)
TTHX1114
Arms:
Group 1a, Group 2 TTHX1114 in combination with DWEK/DSO, Group 3 TTHX1114 in combination with DWEK/DSO, Group 3a
Size
49
Primary endpoint
Best Corrected Visual Acuity
Day 28
Eligibility criteria
Key Inclusion Criteria: * Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months * Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm * Subjects in Group 2 must have a stable Fellow Eye with adequate function Key Exclusion Criteria: * Secondary corneal/ocular pathology in the Study Eye * Prior refractive surgery in the Study Eye * Prior exposure to TTHX1114
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 49, 'type': 'ACTUAL'}}
Updated at
2023-11-07

1 organization

1 product

3 indications

Product
TTHX1114(NM141)
Indication
Fuchs' Endothelial Dystrophy
Indication
Fuchs Endothelial Corneal Dystrophy
Indication
Fuchs
Organization
Trefoil Therapeutics