Endothelial Dysfunction Clinical Trial
— INTREPIDOfficial 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
Verified date | October 2022 |
Source | Trefoil Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Trefoil Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DLTs/ Adverse Reactions | Suspected Adverse Reactions Reported Following Study Drug Adminsitration | Day 90 |
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