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OpenTrials
Completed

NCT Number: NCT04812067

A Safety and Efficacy Trial of TTHX1114 in People With CED

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Trefoil Study Site, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TTHX1114

Drug

engineered FGF-1

Primary outcomes

  1. Specular Microscopy

    Time frame: Day 28

    Corneal Endothelial Cell Density

Secondary outcomes

  1. Pachymetry

    Time frame: Day 28

    Central Corneal Thickness

Sponsors and collaborators

Lead sponsor

Trefoil Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: OPTIC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2021
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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