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CompletedNCT04676737Updated Nov 7, 2023

TTHX1114(NM141) in Combination With DWEK/DSO

A Phase 2 interventional study of TTHX1114(NM141) in Fuchs' Endothelial Dystrophy, Fuchs Dystrophy and Fuchs, sponsored by Trefoil Therapeutics, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Trefoil Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2022, 3 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Fuchs' Endothelial Dystrophy
  • Fuchs Dystrophy
  • Fuchs
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's enrollment of 49 is close to the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Trefoil Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • 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)

  • 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)

  • 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)

  • 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)

Interventions

06

What researchers measure

Primary outcomes

  1. Best Corrected Visual Acuity

    Change from baseline

    Time frame: Day 28

07

Study locations

11 sites
  • Trefoil Investigational Site 124
    Long Beach, California 90805, United States
  • North Bay Eye Associates
    Petaluma, California 94954, United States
  • Trefoil Investigational Site 123
    Deerfield Beach, Florida 33064, United States
  • Trefoil Investigational Site 119
    Fort Myers, Florida 33907, United States
  • Price Vision Group
    Indianapolis, Indiana 46260, United States
  • Tauber Eye Center
    Kansas City, Missouri 64111, United States
  • Vance Thompson Vision - Bozeman
    Bozeman, Montana 59718, United States
  • Vance Thompson Vision - Omaha
    Omaha, Nebraska 68137, United States
  • Vance Thompson Vision - Fargo
    W. Fargo, North Dakota 58078, United States
  • Trefoil Investigational Site 120
    Cincinnati, Ohio 45242, United States
  • Vance Thompson Vision - Sioux Falls
    Sioux Falls, South Dakota 57108, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2021 to primary completion in Nov 2022, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2020
First posted
Dec 21, 2020
StartActual
Feb 1, 2021
Primary completionActual
Nov 16, 2022
CompletionActual
Jan 13, 2023
Last update
Nov 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04676737
Lead sponsor
Trefoil Therapeutics, Inc.
Responsible party
Sponsor
First posted
Dec 21, 2020
Start date
Feb 1, 2021
Primary completion
Nov 16, 2022
Completion
Jan 13, 2023
Last update
Nov 7, 2023

Study contacts

Thomas Tremblay
study director · Trefoil Therapeutics.com

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: TTHX1114

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