A Safety and Efficacy Trial of TTHX1114 in People With CED

NCT04812067 | Completed Phase 2 FDA Drug

• 1 other identifier: TTHX-901
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114

Conditions

Corneal Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• Specular Microscopy

  Corneal Endothelial Cell Density

  Day 28

Secondary Outcomes (1)

• Pachymetry

  Day 28

Study Arms (1)

TTHX1114 weekly x 5

EXPERIMENTAL

TTHX1114 via IC injection weekly x 5

Drug: TTHX1114

Interventions

TTHX1114 DRUG

engineered FGF-1

TTHX1114 weekly x 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
• Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
• Fellow Eye with 20/100 BCVA or better
• No concurrent ocular or medical condition that would impair the assessment of safety and efficacy

You may not qualify if:

• Prior exposure to TTHX1114
• Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
• Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
• History of:
• Ocular cancer (including melanoma)
• Herpetic keratitis
• Documented and repeated elevated IOP in either eye
• Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
• Uveitis
• Use of any concomitant medications that may interfere with the assessment of safety and efficacy
• Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study

Sponsors & Collaborators

• Trefoil Therapeutics, Inc.: lead

Study Sites (2)

Trefoil Study Site

Atlanta, Georgia, 30342, United States

Location

Trefoil Study Site

Washington, Missouri, 30090, United States

Location

MeSH Terms

Conditions

Corneal Dystrophy, Posterior Polymorphous, 1

Study Officials

• Thomas Tremblay

  Trefoil Therapeutics.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: November 30, 2021
• Primary Completion: August 29, 2023
• Study Completion: October 31, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)