A Safety and Efficacy Trial of TTHX1114 in People With CED

A Phase 2 Clinical Trial to Assess the Safety and Observe the Potential Benefit of TTHX1114 Delivered Via Intra-Cameral (IC) Injection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04812067

Acronym

OPTIC

Enrollment

Registered

2021-03-23

Start date

2021-11-30

Completion date

2023-10-31

Last updated

2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Endothelial Dystrophy

Brief summary

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

Interventions

DRUGTTHX1114

engineered FGF-1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Specular Microscopy	Day 28	Corneal Endothelial Cell Density

Secondary

Measure	Time frame	Description
Pachymetry	Day 28	Central Corneal Thickness

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026