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Completed

NCT Number: NCT04520321

A Phase 1/ Phase 2 Study of TTHX1114(NM141)

Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

North Bay Eye Associates, Inc., Petaluma, California, United States

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About this study

This is a prospective, multi-center, randomized, masked, vehicle-controlled, dose-escalation study that will include an observational (no intervention) sub-study. Eligible subjects with moderate to severe corneal endothelial dystrophy (defined as Endothelial Cell Density < 2000 mm^2) in at least one eye will be enrolled and randomized.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Fuchs Endothelial Corneal Dystrophy, pseudophakic bullous keratopathy, or endothelial dysfunction/ insufficiency due to surgical intervention diagnosed more than 6 months prior to Study Day 0
  • Central endothelial cell count of < 2000 mm^2 in at least one eye as determined by the central reading facility

Key Exclusion Criteria:

  • Conditions that would impair examination of the anterior chamber structure
  • Documented repeated elevated intra ocular pressure (in either eye)
  • Corneal transplant (in either eye)
  • Posterior Polymorphous Corneal Dystrophy (PPCD)
  • History of uveitis or herpetic keratitis
  • Cataract surgery within the past 3 months
  • Refractive surgery (in the Study Eye)
  • Anterior Chamber IOL placement (in the Study Eye)
  • Active extra-ocular inflammation from any non-infectious or infectious cause within the past 6 months
  • Expected or planned ocular surgery within the next 3 months
  • Use of cytotoxic chemotherapy within the last 1 month
  • Treatment with a rho kinase inhibitor within the last 3 months
  • Use of cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution in the last 30 days
  • Systemic or ophthalmic corticosteroid use in the 30 days prior to Study Day 0 unless approved by the Medical Monitor
  • History of significant allergy, hypersensitivity, or intolerance to any drug compound, food, or other substance
  • Unwilling to use birth control

Treatment and study plan

TTHX1114(NM141)

Drug

engineered FGF-1 delivered intracamerally

Vehicle (placebo)

Other

Placebo

Primary outcomes

  1. DLTs/ Adverse Reactions

    Time frame: Day 90

    Suspected Adverse Reactions Reported Following Study Drug Adminsitration

Sponsors and collaborators

Lead sponsor

Trefoil Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1/ Phase 2 Study Evaluating the Safety and Efficacy of the Investigational New Drug TTHX1114(NM141) on the Regeneration of Corneal Endothelial Cells in Patients With Corneal Endothelial Dystrophies Following Intracameral Delivery

Acronym: INTREPID

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Oct 30, 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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