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TTHX1114(NM141) in Combination With DWEK/DSO

Primary Purpose

Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TTHX1114(NM141)
Sponsored by
Trefoil Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Trefoil Investigational Site 124
  • North Bay Eye Associates
  • Trefoil Investigational Site 123
  • Trefoil Investigational Site 119
  • Price Vision Group
  • Tauber Eye Center
  • Vance Thompson Vision - Bozeman
  • Vance Thompson Vision - Omaha
  • Vance Thompson Vision - Fargo
  • Trefoil Investigational Site 120
  • Vance Thompson Vision - Sioux Falls

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 DWEK/DSO

Group 2 TTHX1114 in combination with DWEK/DSO

Group 3 TTHX1114 in combination with DWEK/DSO

Group 1a

Group 3a

Arm Description

Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114

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

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

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)

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)

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity
Change from baseline

Secondary Outcome Measures

Full Information

First Posted
December 15, 2020
Last Updated
January 21, 2022
Sponsor
Trefoil Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04676737
Brief Title
TTHX1114(NM141) in Combination With DWEK/DSO
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trefoil Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 DWEK/DSO
Arm Type
No Intervention
Arm Description
Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114
Arm Title
Group 2 TTHX1114 in combination with DWEK/DSO
Arm Type
Experimental
Arm Description
Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
Arm Title
Group 3 TTHX1114 in combination with DWEK/DSO
Arm Type
Experimental
Arm Description
Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
Arm Title
Group 1a
Arm Type
Experimental
Arm Description
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)
Arm Title
Group 3a
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
TTHX1114(NM141)
Intervention Description
TTHX1114
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
Change from baseline
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Tremblay
Organizational Affiliation
Trefoil Therapeutics.com
Official's Role
Study Director
Facility Information:
Facility Name
Trefoil Investigational Site 124
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Trefoil Investigational Site 123
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Trefoil Investigational Site 119
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Vance Thompson Vision - Bozeman
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Vance Thompson Vision - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68137
Country
United States
Facility Name
Vance Thompson Vision - Fargo
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Trefoil Investigational Site 120
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Vance Thompson Vision - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

TTHX1114(NM141) in Combination With DWEK/DSO

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