TTHX1114(NM141) in Combination With DWEK/DSO

Trefoil Therapeutics

Status and phase: Completed; Phase 2

Conditions: Fuchs; Fuchs Dystrophy; Fuchs' Endothelial Dystrophy

Treatments: Drug: TTHX1114(NM141)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04676737

TTHX-002

Details and patient eligibility

About

Open label, single-treatment, with a concurrent non-treatment control

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 5 patient groups

Group 1 DWEK/DSO

No Intervention group

Description:

Study subjects in Group 1 will undergo DWEK/ DSO and will not receive any TTHX1114

Group 2 TTHX1114 in combination with DWEK/DSO

Experimental group

Description:

Study subjects in Group 2 will receive TTHX1114 (5 injections) and undergo DWEK/ DSO

Treatment:

Drug: TTHX1114(NM141)

Group 3 TTHX1114 in combination with DWEK/DSO

Experimental group

Description:

Study subjects in Group 3 will receive TTHX1114 (1 injection) and undergo DWEK/ DSO

Treatment:

Drug: TTHX1114(NM141)

Group 1a

Experimental group

Description:

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)

Treatment:

Drug: TTHX1114(NM141)

Group 3a

Experimental group

Description:

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)

Treatment:

Drug: TTHX1114(NM141)