Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 10 for:    Trefoil | Recruiting, Not yet recruiting Studies

TTHX1114(NM141) in Combination With DWEK/DSO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04676737
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Trefoil Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Fuchs Dystrophy Fuchs Drug: TTHX1114(NM141) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: Day 28 ]
    Change from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676737


Contacts
Layout table for location contacts
Contact: Thomas M Tremblay, RN, BSN +1 (415) 305-3491 ttremblay@trefoiltherapeutics.com

Locations
Layout table for location information
United States, California
Trefoil Investigational Site 124 Recruiting
Long Beach, California, United States, 90805
Contact: Thomas Tremblay    415-305-3491    ttremblay@trefoiltherapeutics.com   
North Bay Eye Associates Recruiting
Petaluma, California, United States, 94954
Contact: Eduardo Chavez    707-769-2240      
United States, Florida
Trefoil Investigational Site 123 Recruiting
Deerfield Beach, Florida, United States, 33064
Contact: Thomas Tremblay    415-305-3491    ttremblay@trefoiltherapeutics.com   
Trefoil Investigational Site 119 Recruiting
Fort Myers, Florida, United States, 33907
Contact: Thomas Tremblay    415-305-3491    ttremblay@trefoiltherapeutics.com   
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Marianne Price, PhD    317-814-2990    mprice@cornea.org   
United States, Missouri
Tauber Eye Center Recruiting
Kansas City, Missouri, United States, 64111
Contact: Megan Hefter, CCRP    816-531-9100      
United States, Montana
Vance Thompson Vision - Bozeman Recruiting
Bozeman, Montana, United States, 59718
Contact    406-219-0700      
United States, Nebraska
Vance Thompson Vision - Omaha Recruiting
Omaha, Nebraska, United States, 68137
Contact    402-704-3236      
United States, North Dakota
Vance Thompson Vision - Fargo Recruiting
W. Fargo, North Dakota, United States, 58078
Contact    701-566-5390      
United States, Ohio
Trefoil Investigational Site 120 Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Thomas Tremblay    415-305-3491    ttremblay@trefoiltherapeutics.com   
United States, South Dakota
Vance Thompson Vision - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact    605-231-9716      
Sponsors and Collaborators
Trefoil Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Thomas Tremblay Trefoil Therapeutics.com
Layout table for additonal information
Responsible Party: Trefoil Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04676737    
Other Study ID Numbers: TTHX-002
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn