TTHX1114(NM141) in Combination With DWEK/DSO

November 6, 2023 updated by: Trefoil Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90805
        • Trefoil Investigational Site 124
      • Petaluma, California, United States, 94954
        • North Bay Eye Associates
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Trefoil Investigational Site 123
      • Fort Myers, Florida, United States, 33907
        • Trefoil Investigational Site 119
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
    • Montana
      • Bozeman, Montana, United States, 59718
        • Vance Thompson Vision - Bozeman
    • Nebraska
      • Omaha, Nebraska, United States, 68137
        • Vance Thompson Vision - Omaha
    • North Dakota
      • W. Fargo, North Dakota, United States, 58078
        • Vance Thompson Vision - Fargo
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Trefoil Investigational Site 120
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Vance Thompson Vision - Sioux Falls

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity
Time Frame: Day 28
Change from baseline
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trefoil Therapeutics, Inc.

Investigators

  • Study Director: Thomas Tremblay, Trefoil Therapeutics.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

January 13, 2023

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTHX-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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