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

November 6, 2023 updated by: Trefoil Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Trefoil Study Site
    • Missouri
      • Washington, Missouri, United States, 30090
        • Trefoil Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specular Microscopy
Time Frame: Day 28
Corneal Endothelial Cell Density
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pachymetry
Time Frame: Day 28
Central Corneal Thickness
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trefoil Therapeutics, Inc.

Investigators

  • Study Director: Thomas Tremblay, Trefoil Therapeutics.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Actual)

August 29, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TTHX-901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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