Phase 2
Completed N=22
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
Corneal Endothelial Dystrophy · Fuchs endothelial corneal dystrophy · pseudophakic bullous keratopathy · Endothelial Dysfunction
Source: ClinicalTrials.gov NCT04520321 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: DLTs/ Adverse Reactions — 0; 0; 0; 0 Participants
Summary
Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY DLTs/ Adverse Reactions |
0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04520321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.