A Safety and Efficacy Trial of TTHX1114 in People With CED

Corneal Endothelial Dystrophy Clinical Trial

— OPTIC  

Official title:

A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812067
• Other study ID #: TTHX-901
• Status: Completed
• Phase: Phase 2
• Start date: November 30, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Trefoil Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 31, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Endothelial Dystrophy

Intervention

Drug:
• TTHX1114
engineered FGF-1

Locations

Country	Name	City	State
United States	Trefoil Study Site	Atlanta	Georgia
United States	Trefoil Study Site	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Trefoil Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specular Microscopy	Corneal Endothelial Cell Density	Day 28
Secondary	Pachymetry	Central Corneal Thickness	Day 28