A Phase 1/ Phase 2 Study of TTHX1114(NM141)

A Phase 1/ Phase 2 Study Evaluating the Safety and Efficacy of the Investigational New Drug TTHX1114(NM141) on the Regeneration of Corneal Endothelial Cells in Patients With Corneal Endothelial Dystrophies Following Intracameral Delivery

Sponsors

Lead Sponsor: Trefoil Therapeutics, Inc.

Source Trefoil Therapeutics, Inc.
Brief Summary

Prospective, multicenter, randomized, masked, vehicle-controlled, dose-escalation study that includes a non-interventional observational sub-study in which subjects will undergo (standard) ocular assessments

Detailed Description

This is a prospective, multi-center, randomized, masked, vehicle-controlled, dose-escalation study that will include an observational (no intervention) sub-study. Up to 71 eligible subjects with moderate to severe corneal endothelial dystrophy (defined as Endothelial Cell Density < 2000 mm^2) in at least one eye will be enrolled and randomized in the main study. The Observational Sub-study will enroll approximately 25 to 50 subjects.

Overall Status Recruiting
Start Date August 19, 2020
Completion Date December 2021
Primary Completion Date August 2021
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Corneal Endothelial Cell Count 56 Days
Enrollment 22
Condition
Intervention

Intervention Type: Drug

Intervention Name: TTHX1114(NM141)

Description: engineered FGF-1 delivered intracamerally

Intervention Type: Other

Intervention Name: Vehicle (placebo)

Description: Placebo

Arm Group Label: Vehicle (placebo)

Eligibility

Criteria:

Key Inclusion Criteria: - Fuchs Endothelial Corneal Dystrophy, pseudophakic bullous keratopathy, or endothelial dysfunction/ insufficiency due to surgical intervention diagnosed more than 6 months prior to Study Day 0 - Central endothelial cell count of < 2000 mm^2 in at least one eye as determined by the central reading facility Key Exclusion Criteria: - Conditions that would impair examination of the anterior chamber structure - Documented repeated elevated intra ocular pressure (in either eye) - Corneal transplant (in either eye) - Posterior Polymorphous Corneal Dystrophy (PPCD) - History of uveitis or herpetic keratitis - Cataract surgery within the past 3 months - Refractive surgery (in the Study Eye) - Anterior Chamber IOL placement (in the Study Eye) - Active extra-ocular inflammation from any non-infectious or infectious cause within the past 6 months - Expected or planned ocular surgery within the next 3 months - Use of cytotoxic chemotherapy within the last 1 month - Treatment with a rho kinase inhibitor within the last 3 months - Use of cyclosporine ophthalmic emulsion or lifitegrast ophthalmic solution in the last 30 days - Systemic or ophthalmic corticosteroid use in the 30 days prior to Study Day 0 unless approved by the Medical Monitor - History of significant allergy, hypersensitivity, or intolerance to any drug compound, food, or other substance - Unwilling to use birth control

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Thomas M Tremblay, RN BSN Study Director Trefoil Therapeutics
Overall Contact

Last Name: Thomas M Tremblay, RN BSN

Phone: (415) 305-3491

Email: [email protected]

Location
Facility: Status: Contact:
North Bay Eye Associates, Inc. | Petaluma, California, 94954, United States Recruiting Eduardo Chavez 707-769-2240
Levenson Eye Associates, Inc | Jacksonville, Florida, 32204, United States Recruiting Vontrece Williams 904-701-2417
Chicago Corneal Consultants | Hoffman Estates, Illinois, 60169, United States Recruiting Parag Majmudar, MD
Price Vision Group | Indianapolis, Indiana, 46260, United States Recruiting Marianne Price, PhD 317-814-2990 [email protected]
Tauber Eye Center | Kansas City, Missouri, 64111, United States Recruiting Megan Hefter
Vance Thompson Vision - Omaha | Omaha, Nebraska, 68137, United States Recruiting 402-704-3236
Alterman, Modi and Wolter | Poughkeepsie, New York, 12603, United States Recruiting Sarah Ortiz Piza 204
Vance Thompson Vision - Sioux Falls | Sioux Falls, South Dakota, 57108, United States Recruiting 605-231-9716
Location Countries

United States

Verification Date

December 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Vehicle (placebo)

Type: Placebo Comparator

Description: Placebo weekly x 4

Label: Low dose

Type: Experimental

Description: TTHX1114(NM141) low-dose weekly x 4

Label: Mid-dose

Type: Experimental

Description: TTHX1114(NM141) mid-dose weekly x 4

Label: High-dose

Type: Experimental

Description: TTHX1114(NM141) high-dose weekly x 4

Acronym INTREPID
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized, Masked, Vehicle-controlled, Dose-escalation study

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov

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