NCT04520321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

August 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

October 30, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

August 14, 2020

Results QC Date

October 31, 2022

Last Update Submit

October 27, 2023

Conditions

Corneal Endothelial DystrophyFuchs Endothelial Corneal DystrophyPseudophakic Bullous KeratopathyEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • DLTs/ Adverse Reactions

    Suspected Adverse Reactions Reported Following Study Drug Adminsitration

    Day 90

Study Arms (4)

Vehicle (placebo)

PLACEBO COMPARATOR

Placebo weekly x 4

Other: Vehicle (placebo)

Low dose

EXPERIMENTAL

TTHX1114(NM141) low-dose weekly x 4

Drug: TTHX1114(NM141)

Mid-dose

EXPERIMENTAL

TTHX1114(NM141) mid-dose weekly x 4

Drug: TTHX1114(NM141)

High-dose

EXPERIMENTAL

TTHX1114(NM141) high-dose weekly x 4

Drug: TTHX1114(NM141)

Interventions

TTHX1114(NM141)DRUG

engineered FGF-1 delivered intracamerally

High-doseLow doseMid-dose
Vehicle (placebo)OTHER

Placebo

Vehicle (placebo)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

Levenson Eye Associates, Inc

Jacksonville, Florida, 32204, United States

Location

Chicago Corneal Consultants

Hoffman Estates, Illinois, 60169, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Vance Thompson Vision - Omaha

Omaha, Nebraska, 68137, United States

Location

Alterman, Modi and Wolter

Poughkeepsie, New York, 12603, United States

Location

Vance Thompson Vision - Sioux Falls

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Corneal Dystrophy, Posterior Polymorphous, 1Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title
Thomas M Tremblay, RN, BSN
Organization
Trefoil Therapeutics.com
ttremblay@trefoiltherapeutics.com
4153053491

Study Officials

  • Thomas M Tremblay, RN BSN

    Trefoil Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Masked, Vehicle-controlled, Dose-escalation study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 20, 2020

Study Start

August 19, 2020

Primary Completion

April 23, 2021

Study Completion

May 18, 2021

Last Updated

October 30, 2023

Results First Posted

October 30, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(8)