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TTHX1114 for Corneal Endothelial Regeneration (INTREPID)
NCT04520321Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2020
- Primary completion
- Apr 2021
- Countries
- 1
- Sponsor
- Trefoil Therapeutics
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- TTHX1114
- Conditions
- Fuchs endothelial dystrophy (FED)Fuchs endothelial corneal dystrophy (FECD)pseudophakic bullous keratopathy (PBK)endothelial dysfunction
01
Overview
Phase 2, randomised, double-blind trial of TTHX1114 in Fuchs endothelial dystrophy (FED), Fuchs endothelial corneal dystrophy (FECD), pseudophakic bullous keratopathy (PBK) and 1 more (4 arms), sponsored by Trefoil Therapeutics. Primary endpoint: Dose Limiting Toxicities/Adverse Reactions at Day 90. Started Aug 2020; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Vehicle
Placebo weekly x 4
Low dose
TTHX1114 low-dose weekly x 4
Mid-dose
TTHX1114 mid-dose weekly x 4
High-dose
TTHX1114 high-dose weekly x 4
03
Who it enrols
Patients with moderate to severe corneal endothelial dystrophy (FECD, PBK, or endothelial dysfunction) with cell count < 2000 mm^2.
04
Endpoints
Primary
Dose Limiting Toxicities/Adverse Reactions
Secondary
Change in Corneal Endothelial Cell Count
Visual Acuity
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