Status:
COMPLETED
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
Lead Sponsor:
Trefoil Therapeutics, Inc.
Conditions:
Corneal Endothelial Dystrophy
Fuchs Endothelial Corneal Dystrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
Detailed 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 se...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04520321
Start Date
August 19 2020
End Date
May 18 2021
Last Update
October 30 2023
Active Locations (8)
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1
North Bay Eye Associates, Inc.
Petaluma, California, United States, 94954
2
Levenson Eye Associates, Inc
Jacksonville, Florida, United States, 32204
3
Chicago Corneal Consultants
Hoffman Estates, Illinois, United States, 60169
4
Price Vision Group
Indianapolis, Indiana, United States, 46260