TTHX1114(NM141) in Combination With DWEK/DSO
Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs
About this trial
This is an interventional treatment trial for Fuchs' Endothelial Dystrophy
Eligibility Criteria
Key Inclusion Criteria:
- Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
- Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
- Subjects in Group 2 must have a stable Fellow Eye with adequate function
Key Exclusion Criteria:
- Secondary corneal/ocular pathology in the Study Eye
- Prior refractive surgery in the Study Eye
- Prior exposure to TTHX1114
Sites / Locations
- Trefoil Investigational Site 124
- North Bay Eye Associates
- Trefoil Investigational Site 123
- Trefoil Investigational Site 119
- Price Vision Group
- Tauber Eye Center
- Vance Thompson Vision - Bozeman
- Vance Thompson Vision - Omaha
- Vance Thompson Vision - Fargo
- Trefoil Investigational Site 120
- Vance Thompson Vision - Sioux Falls
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
No Intervention
Experimental
Experimental
Experimental
Experimental
Group 1 DWEK/DSO
Group 2 TTHX1114 in combination with DWEK/DSO
Group 3 TTHX1114 in combination with DWEK/DSO
Group 1a
Group 3a
Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114
Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO
Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO
Study subjects in Group 1a will consist of subjects in Group 1 if not recovered from DWEK/ DSO by Day 84 and will receive TTHX1114 (5 injections)
Study subjects in Group 3a will consist of subjects who had participated in in Group 3 if not recovered from DWEK/ DSO by the median time observed in Group 2 and will receive TTHX1114 (4 injections)