NCT04676737

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

November 7, 2023

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

December 15, 2020

Last Update Submit

November 6, 2023

Conditions

Fuchs' Endothelial DystrophyFuchs DystrophyFuchs

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity

    Change from baseline

    Day 28

Study Arms (5)

Group 1 DWEK/DSO

NO INTERVENTION

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

Group 2 TTHX1114 in combination with DWEK/DSO

EXPERIMENTAL

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

Drug: TTHX1114(NM141)

Group 3 TTHX1114 in combination with DWEK/DSO

EXPERIMENTAL

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

Drug: TTHX1114(NM141)

Group 1a

EXPERIMENTAL

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)

Group 3a

EXPERIMENTAL

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

TTHX1114(NM141)DRUG

TTHX1114

Group 1aGroup 2 TTHX1114 in combination with DWEK/DSOGroup 3 TTHX1114 in combination with DWEK/DSOGroup 3a

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary corneal/ocular pathology in the Study Eye
  • Prior refractive surgery in the Study Eye
  • Prior exposure to TTHX1114

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Trefoil Investigational Site 124

Long Beach, California, 90805, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Trefoil Investigational Site 123

Deerfield Beach, Florida, 33064, United States

Location

Trefoil Investigational Site 119

Fort Myers, Florida, 33907, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Vance Thompson Vision - Bozeman

Bozeman, Montana, 59718, United States

Location

Vance Thompson Vision - Omaha

Omaha, Nebraska, 68137, United States

Location

Vance Thompson Vision - Fargo

West Fargo, North Dakota, 58078, United States

Location

Trefoil Investigational Site 120

Cincinnati, Ohio, 45242, United States

Location

Vance Thompson Vision - Sioux Falls

Sioux Falls, South Dakota, 57108, United States

Location

Related Publications (1)

  • Moloney G, Al-Zanki S, Burgos-Blasco B, Fadaifard Martinez M, Bujak M, Dhaliwal DK. Severe Corneal Flattening After Endothelial Keratoplasty: Collagen Compaction Syndrome. Cornea. 2024 Nov 7;44(5):653-658. doi: 10.1097/ICO.0000000000003752.

    PMID: 39509248DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Thomas Tremblay

    Trefoil Therapeutics.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2020

First Posted

December 21, 2020

Study Start

February 1, 2021

Primary Completion

November 16, 2022

Study Completion

January 13, 2023

Last Updated

November 7, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(11)