TTHX1114(NM141) in Combination With DWEK/DSO

Phase 2

Completed

• Conditions: Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Fuchs
• Interventions: Drug: TTHX1114(NM141)

• Registration Number: NCT04676737
• Lead Sponsor: Trefoil Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-15
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-21
• Study Start: 2021-02-01
• Primary Completion: 2022-11-16
• Status Verified: 2022-12
• Study Completion: 2023-01-13
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 TTHX1114 in combination with DWEK/DSO	TTHX1114(NM141)	Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
Group 3 TTHX1114 in combination with DWEK/DSO	TTHX1114(NM141)	Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
Group 1a	TTHX1114(NM141)	Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections)
Group 3a	TTHX1114(NM141)	Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections)

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	Day 28	Change from baseline

Trial Locations

Locations (11)

Vance Thompson Vision - Sioux Falls; 🇺🇸 Sioux Falls, South Dakota, United States

Trefoil Investigational Site 120; 🇺🇸 Cincinnati, Ohio, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Trefoil Investigational Site 124; 🇺🇸 Long Beach, California, United States

Trefoil Investigational Site 123; 🇺🇸 Deerfield Beach, Florida, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Trefoil Investigational Site 119; 🇺🇸 Fort Myers, Florida, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

Vance Thompson Vision - Omaha; 🇺🇸 Omaha, Nebraska, United States

Vance Thompson Vision - Fargo; 🇺🇸 W. Fargo, North Dakota, United States

Vance Thompson Vision - Bozeman; 🇺🇸 Bozeman, Montana, United States