OPTIC: A Safety and Efficacy Trial of TTHX1114 in People With CED

• Sponsor: Trefoil Therapeutics, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04812067
• Collaborator: (none)
• Enrollment: 24
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 25
• Patients Per Site: 12
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Endothelial Dystrophy	Drug: TTHX1114	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection
• Actual Study Start Date: Nov 30, 2021
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TTHX1114 weekly x 5 TTHX1114 via IC injection weekly x 5	Drug: TTHX1114; engineered FGF-1

Outcome Measures

Primary Outcome Measures

1. Specular Microscopy [Day 28]

   Corneal Endothelial Cell Density

Secondary Outcome Measures

1. Pachymetry [Day 28]

   Central Corneal Thickness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trefoil Study Site	Atlanta	Georgia	United States	30342
2	Trefoil Study Site	Washington	Missouri	United States	30090

Sponsors and Collaborators

• Trefoil Therapeutics, Inc.

Investigators

• Study Director: Thomas Tremblay, Trefoil Therapeutics.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Trefoil Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04812067
• Other Study ID Numbers: TTHX-901
• First Posted: Mar 23, 2021
• Last Update Posted: Jan 25, 2022
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 25, 2022