Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

NCT ID: NCT04909450

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-24
• Study Completion Date: 2024-06-04

Brief Summary

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

Conditions

Neurotrophic Keratitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CSB-001 Investigational Treatment Arm

One drop CSB-001 four times daily for 8 weeks in the study eye

Group Type: EXPERIMENTAL

CSB-001 Ophthalmic Solution 0.1%

Intervention Type: BIOLOGICAL

CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Vehicle Control Arm

One drop matching vehicle four times daily for 8 weeks in the study eye

Group Type: PLACEBO_COMPARATOR

Vehicle Control

Intervention Type: BIOLOGICAL

Matching vehicle control without the drug substance

Interventions

CSB-001 Ophthalmic Solution 0.1%

CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Intervention Type: BIOLOGICAL

Vehicle Control

Matching vehicle control without the drug substance

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK). Subjects with bilateral NK may enroll in the study but only one eye will be selected as the study eye (worse eye) and be treated with test article.
• Subjects with no clinical evidence of improvement in the PED or corneal ulcer within the 2 weeks prior to study enrollment despite the use of conventional non-surgical treatments for neurotrophic keratitis (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops and medications that can decrease corneal sensitivity; therapeutic contact lenses [either silicone hydrogel or rigid gas permeable]) as determined by the investigator or referring physician's medical record.
• Subjects with clinical evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant in the study eye in the opinion of the investigator assessed with a cotton wisp.
• Pinhole distance visual acuity score ≤ 75 ETDRS letters measured with a LogMAR chart (≥ 0.2 LogMAR, ≤ 20/32 Snellen or worse Snellen or ≤ 0.625 decimal fraction) in the study eye.
• Subjects must have the ability and willingness to comply with study procedures.

Exclusion Criteria

• Any active ocular infection (bacterial, viral, fungal, or protozoal) or active ocular inflammation not related to NK in either eye in the opinion of the investigator. Infectious epithelial keratitis including herpetic keratitis (i.e., dendritic lesions or geographic ulcers) in either eye is excluded. Subjects on oral antibiotic at the time of screening are eligible but should continue the medication for the duration of the study.
• Previous use of Oxervate in the study eye with last administration within the past 2 months.
• Any other ocular disease, except glaucoma, that will require topical ocular treatment in the study eye over the course of the study.
• Use of any other topical treatments other than the study medication provided by the Sponsor and allowed by the study protocol can be administered to the study eye over the course of the study. The following are exceptions: a) Allowance for use of preservative-free antibiotic eye drops if prescribed by the investigator and b) Allowance for use of a non-preserved IOP-lowering prostaglandin topical ocular drop administered once-daily (QD) in glaucomatous eyes over the course of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claris Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye Care North

Cave Creek, Arizona, United States

Loma Linda University Eye Institute

Loma Linda, California, United States

Nvision Clinical Research, LLC

Los Angeles, California, United States

Global Research Foundation

Los Angeles, California, United States

UCLA Stein Eye Institute

Los Angeles, California, United States

LoBue Laser and Eye Medical Center, Inc.

Murrieta, California, United States

California Eye Specialists Medical Group Inc.

Pasadena, California, United States

Martel Eye Medical Group

Rancho Cordova, California, United States

Gordon Schanzlin New Vision Institute

San Diego, California, United States

Atlantis Eyecare

Torrance, California, United States

University of Colorado - Dept. of Ophthalmology

Aurora, Colorado, United States

Vision Institute

Colorado Springs, Colorado, United States

Corneal Consultants of Colorado

Littleton, Colorado, United States

Advanced Research

Boynton Beach, Florida, United States

Bowden Eye and Associates

Jacksonville, Florida, United States

International Eye Associates, PA

Ormond Beach, Florida, United States

Bascom Palmer Eye Institute at Palm Beach Gardens

Palm Beach, Florida, United States

International Research Center

Tampa, Florida, United States

Eye Consultants of Atlanta

Atlanta, Georgia, United States

Midwest Cornea Associates, LLC

Carmel, Indiana, United States

Price Vision Group

Indianapolis, Indiana, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Kentucky Eye Institute

Lexington, Kentucky, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, United States

Minnesota Eye Consultants

Minnetonka, Minnesota, United States

Tauber Eye Center

Kansas City, Missouri, United States

Ophthalmology Associates

St Louis, Missouri, United States

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, United States

SightMD

Babylon, New York, United States

Cornea Consultants of Albany

Slingerlands, New York, United States

Duke Eye Center

Durham, North Carolina, United States

Eye Consultants of North Dakota

Fargo, North Dakota, United States

The Ohio State University, Department of Ophthalmology and Visual Sciences

Columbus, Ohio, United States

Devers Eye Institute

Portland, Oregon, United States

Hazleton Eye Specialists

Hazle Township, Pennsylvania, United States

Scheie Eye Institute

Philadelphia, Pennsylvania, United States

UPMC Eye Center

Pittsburgh, Pennsylvania, United States

Carolina Cataract & Laser Center

Ladson, South Carolina, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

BLINK Research Center, LLC

Memphis, Tennessee, United States

University of Texas at Austin; The Mitchel and Shannon Wong Eye Institute

Austin, Texas, United States

Stuart A. Terry, MD PA

San Antonio, Texas, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

Dr. Gregory Moloney

Vancouver, British Columbia, Canada

Precision Cornea Centre

Ottawa, Ontario, Canada

Kensington Eye Institute

Toronto, Ontario, Canada

Countries

United States; Canada

References

Hamrah P, Yavuz Saricay L, Ozmen MC. Cutting Edge: Topical Recombinant Nerve Growth Factor for the Treatment of Neurotrophic Keratopathy-Biologicals as a Novel Therapy for Neurotrophic Keratopathy. Cornea. 2022 Jun 1;41(6):673-679. doi: 10.1097/ICO.0000000000002974. Epub 2022 Feb 2.

Reference Type: DERIVED

PMID: 35266655 (View on PubMed)

Other Identifiers

CSB-C20-003

Identifier Type: -

Identifier Source: org_study_id