TTHX1114 for Fuchs' Dystrophy

(OPTIC Trial)

No longer recruiting at 3 trial locations

Overseen By Thomas Tremblay

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Trefoil Therapeutics, Inc.

Must not be taking: Interfering medications

Disqualifiers: Ocular cancer, Herpetic keratitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a treatment called TTHX1114 for individuals with certain eye conditions. The treatment involves an injection into the eye, administered once a week for five weeks. The trial seeks participants with eye issues that might improve with this treatment, as determined by a doctor, and who have good vision in their other eye. Individuals with previous exposure to TTHX1114 or certain eye diseases or allergies may not qualify for participation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that you cannot use any medications that might interfere with the study's safety and efficacy assessments. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that TTHX1114 is likely to be safe for humans?

Research has shown that TTHX1114 has been tested in people before, with promising results. An earlier study found no serious safety side effects, indicating that patients did not experience major health problems from the treatment. This suggests that TTHX1114 might be safe for people. It is important to remember that this trial aims to gather more information on the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for corneal endothelial dystrophy (CED), which typically involves corneal transplants, TTHX1114 offers a novel approach by using a unique active ingredient. TTHX1114 is administered through an intracameral (IC) injection directly into the eye, which is less invasive than surgery. Researchers are excited about TTHX1114 because it potentially stimulates the regeneration of corneal endothelial cells, targeting the root cause of CED rather than just managing symptoms. This innovative mechanism of action could represent a significant advancement over current treatments, offering hope for improved vision and quality of life for patients.

What evidence suggests that TTHX1114 might be an effective treatment for CED?

Research has shown that TTHX1114, which participants in this trial will receive, can improve vision in people with corneal endothelial dystrophy (CED). Studies have found that TTHX1114 promotes the growth of new cells in the eye, which are crucial for maintaining eye health. In a previous trial, patients experienced better vision, with many noticing improvements within a few weeks. Some even achieved 20/40 vision on average about 4.2 weeks after treatment. This treatment also speeds up vision recovery and maintains a clear and healthy cornea. ^{1 6 7 8 9}

Who Is on the Research Team?

Thomas Tremblay

Principal Investigator

Trefoil Therapeutics.com

Are You a Good Fit for This Trial?

Inclusion Criteria

You are a woman of childbearing potential (WOCBP).

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

No concurrent ocular or medical condition that would impair the assessment of safety and efficacy

Exclusion Criteria

You have a condition called uveitis.

You have had eye cancer in the past (including melanoma).

Documented and repeated elevated IOP in either eye

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TTHX1114 via intra-cameral injection weekly for 5 weeks

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TTHX1114

How Is the Trial Designed?

Group I: TTHX1114 weekly x 5 Experimental Treatment 1 Intervention

TTHX1114 via IC injection weekly x 5

Who Is Running the Clinical Trial?

Trefoil Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

120+

Citations

1. trefoiltherapeutics.com trefoiltherapeutics.com/trefoil-therapeutics-announces-positive-tthx1114-phase-2-study-data-showing-corneal-regeneration-and-vision-recovery-following-descemet-stripping-only-dso-surgery/

Trefoil Therapeutics Announces Positive TTHX1114 Phase ... “The STORM trial data show endothelial cell restoration and patient-reported visual recovery that indicate endothelial cells are regenerating, ...

2. cornealdystrophyfoundation.org cornealdystrophyfoundation.org/positive-phase-2-study-results-presented-at-the-world-cornea-congress-from-trefoil-therapeutics/

Positive Phase 2 study results presented at the World ... The STORM trial data show endothelial cell restoration and patient-reported visual recovery that indicate endothelial cells are regenerating and ...

3. glaucomatoday.com glaucomatoday.com/articles/2024-jan-feb-insert3/the-potential-of-fibroblast-growth-factors-in-corneal-disease

The Potential of Fibroblast Growth Factors in Corneal ... Effectiveness outcomes with TTHX1114 in the STORM 2 clinical trial. Furthermore, 46% of the enrolled patients underwent cataract surgery concurrently with ...

4. ophthalmologytimes.com ophthalmologytimes.com/view/ascrs-2023-trefoil-therapeutics-tthx1114-improves-rate-of-visual-recovery-after-dso-in-phase-2-storm-data

ASCRS 2023: Trefoil Therapeutics' TTHX1114 improves ... TTHX1114 was found to improve the rate of visual recovery and corneal deturgescence (state of relative dehydration maintained by the normal cornea that is ...

5. ophthalmology360.com ophthalmology360.com/cornea-and-external-disease/positive-trial-results-announced-for-tthx1114-in-patients-with-fuchs-endothelial-corneal-dystrophy/

Positive trial results announced for TTHX1114 in patients ... After a single intracameral injection of TTHX1114 in the Phase 2 STORM trial, vision was restored to 20/40 in a mean time of 4.2 weeks following DSO and was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11345243/

Safety of intraoperative autologous plasma incubation ... In our study, both plasma products proved to be safe. No serious side effects were noted in any of our patients. Intracameral PRGF-Endoret ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034696/

Therapeutic future of Fuchs endothelial corneal dystrophy [88] One clinical trial investigates the ability of TTHX1114 to treat FECD,[75] and another clinical trial tests its effects in patients post- ...

8. drug-dev.com drug-dev.com/therapeutic-focus-tthx1114-improving-outcomes-for-high-risk-patients-after-cataract-surgery/

Improving Outcomes for High-Risk Patients After Cataract ... While the surgery is generally safe and effective, there are still certain risks associated with the procedure, particularly in patients with ...

9. trefoiltherapeutics.com trefoiltherapeutics.com/trefoil-therapeutics-announces-first-patient-dosed-in-phase-1-study-of-tthx1114-for-treatment-of-corneal-epithelial-defects/

About TTHX1114 Symptoms include severe pain and blurred vision, and potential vision loss; complications can include corneal scarring, development of glaucoma ...