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

Endothelial Dysfunction Clinical Trial

— INTREPID  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520321
• Other study ID #: TTHX-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 19, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: October 2022
• Source: Trefoil Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 18, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Corneal Endothelial Dystrophy
• Endothelial Dysfunction
• Fuchs Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy
• Pseudophakic Bullous Keratopathy

Intervention

Drug:
• TTHX1114(NM141)
engineered FGF-1 delivered intracamerally

Other:
• Vehicle (placebo)
Placebo

Locations

Country	Name	City	State
United States	Chicago Corneal Consultants	Hoffman Estates	Illinois
United States	Price Vision Group	Indianapolis	Indiana
United States	Levenson Eye Associates, Inc	Jacksonville	Florida
United States	Tauber Eye Center	Kansas City	Missouri
United States	Vance Thompson Vision - Omaha	Omaha	Nebraska
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Alterman, Modi and Wolter	Poughkeepsie	New York
United States	Vance Thompson Vision - Sioux Falls	Sioux Falls	South Dakota

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	DLTs/ Adverse Reactions	Suspected Adverse Reactions Reported Following Study Drug Adminsitration	Day 90