A Safety and Efficacy Trial of TTHX1114 in People With CED

Phase 2

Completed

• Conditions: Corneal Endothelial Dystrophy
• Interventions: Drug: TTHX1114

• Registration Number: NCT04812067
• Lead Sponsor: Trefoil Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Study Start: 2021-11-30
• Primary Completion: 2023-08-29
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TTHX1114 weekly x 5	TTHX1114	TTHX1114 via IC injection weekly x 5

Primary Outcome Measures

Name	Time	Method
Specular Microscopy	Day 28	Corneal Endothelial Cell Density

Secondary Outcome Measures

Name	Time	Method
Pachymetry	Day 28	Central Corneal Thickness

Trial Locations

Locations (1)

Trefoil Study Site; 🇺🇸 Washington, Missouri, United States