A Safety and Efficacy Trial of TTHX1114 in People With CED (OPTIC)

Trefoil Therapeutics

Status and phase

Completed

Phase 2

Conditions

Corneal Endothelial Dystrophy

Treatments

Drug: TTHX1114

Study type

Interventional

Funder types

Industry

Identifiers

TTHX-901

Details and patient eligibility

About

Expanded access, open label study at a single dose level in patients with CED that in the opinion of the investigators might benefit from TTHX1114

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, 18 years of age or older
Subjects who are women of childbearing potential (WOCBP) must be using an acceptable method of birth control (See Section 6.4.3)
Proposed Study Eye that has been diagnosed with an ocular condition that, in the opinion of the Investigator, could possibly benefit from TTHX1114 administration, and has a measurable efficacy endpoint
Fellow Eye with 20/100 BCVA or better
No concurrent ocular or medical condition that would impair the assessment of safety and efficacy

Exclusion criteria

Prior exposure to TTHX1114
Intolerance, hypersensitivity, or significant allergy to any drug compound, food, or other substance (Note: This includes all components and excipients of the study drug)
Current or recent (e.g., the 28 days prior to Study Day 0) participation in any other, interventional clinical research study
History of:
- Ocular cancer (including melanoma)
- Herpetic keratitis
- Documented and repeated elevated IOP in either eye
- Posterior Polymorphous Corneal Dystrophy (PPCD; aka Schlichting dystrophy)
- Uveitis
Use of any concomitant medications that may interfere with the assessment of safety and efficacy
Any other reason (e.g., serious systemic disease or uncontrolled medical condition) that, in the opinion of the Investigator could increase the subject's risk, interfere with the interpretation of the study results, or affect the subject's ability to provide informed consent or comply with the study