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TTHX1114(NM141) in Combination With DWEK/DSO

Sponsor
Trefoil Therapeutics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04676737
Collaborator
(none)
40
Enrollment
11
Locations
5
Arms
22.9
Anticipated Duration (Months)
3.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Group 1 DWEK/DSO

Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114
Experimental: Group 2 TTHX1114 in combination with DWEK/DSO

Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO

Drug: TTHX1114(NM141)
TTHX1114
Experimental: Group 3 TTHX1114 in combination with DWEK/DSO

Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO

Drug: TTHX1114(NM141)
TTHX1114
Experimental: Group 1a

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)

Drug: TTHX1114(NM141)
TTHX1114
Experimental: Group 3a

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)

Drug: TTHX1114(NM141)
TTHX1114

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Visual Acuity [Day 28]

    Change from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Trefoil Investigational Site 124 Long Beach California United States 90805
2 North Bay Eye Associates Petaluma California United States 94954
3 Trefoil Investigational Site 123 Deerfield Beach Florida United States 33064
4 Trefoil Investigational Site 119 Fort Myers Florida United States 33907
5 Price Vision Group Indianapolis Indiana United States 46260
6 Tauber Eye Center Kansas City Missouri United States 64111
7 Vance Thompson Vision - Bozeman Bozeman Montana United States 59718
8 Vance Thompson Vision - Omaha Omaha Nebraska United States 68137
9 Vance Thompson Vision - Fargo W. Fargo North Dakota United States 58078
10 Trefoil Investigational Site 120 Cincinnati Ohio United States 45242
11 Vance Thompson Vision - Sioux Falls Sioux Falls South Dakota United States 57108

Sponsors and Collaborators

  • Trefoil Therapeutics, Inc.

Investigators

  • Study Director: Thomas Tremblay, Trefoil Therapeutics.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trefoil Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04676737
Other Study ID Numbers:
  • TTHX-002
First Posted:
Dec 21, 2020
Last Update Posted:
Jan 25, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Jan 25, 2022