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NCT04676737 Clinical Trial

TTHX1114(NM141) in Combination With DWEK/DSO

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04676737
Other study ID # TTHX-002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 1, 2021
Est. completion date January 13, 2023

Study information
Verified date December 2022
Source Trefoil Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open label, single-treatment, with a concurrent non-treatment control

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date January 13, 2023
Est. primary completion date November 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TTHX1114(NM141)
TTHX1114

Locations
Country Name City State
United States Vance Thompson Vision - Bozeman Bozeman Montana
United States Trefoil Investigational Site 120 Cincinnati Ohio
United States Trefoil Investigational Site 123 Deerfield Beach Florida
United States Trefoil Investigational Site 119 Fort Myers Florida
United States Price Vision Group Indianapolis Indiana
United States Tauber Eye Center Kansas City Missouri
United States Trefoil Investigational Site 124 Long Beach California
United States Vance Thompson Vision - Omaha Omaha Nebraska
United States North Bay Eye Associates Petaluma California
United States Vance Thompson Vision - Sioux Falls Sioux Falls South Dakota
United States Vance Thompson Vision - Fargo W. Fargo North Dakota

Sponsors (1)
Lead Sponsor Collaborator
Trefoil Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Corrected Visual Acuity Change from baseline Day 28
See also
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