A Study Assessing KB801 for the Treatment of Stage 2 or 3 Neurotrophic Keratitis
NCT ID: NCT06999733
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2025-05-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KB801
KB801
Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF)
Placebo
Placebo
Vehicle
Interventions
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KB801
Ophthalmic suspension of replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-based vector delivering functional, full-length human nerve growth factor (NGF)
Placebo
Vehicle
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 18 years at the time of informed consent.
3. Diagnosis of Stage 2 or Stage 3 NK, as defined by the Mackie criteria.
4. Persistent corneal epithelial defect (PCED) of at least 2 weeks duration without clinical improvement during that time. PCED is defined as a focal loss of the cornea's outermost cell layer and can include involvement of the deeper stromal layers (i.e., corneal ulcer).
5. PCED at Screening 1 must have a minimum of 1 mm of any linear measurement of defect.
6. Decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet esthesiometer \[CBE\]) within the area of the PCED and in at least one corneal quadrant outside of the area of the defect.
7. A negative pregnancy test at Screening 1 and Day 1 for women of child-bearing potential.
Exclusion Criteria
2. Use of any prohibited therapies at Screening or anticipated need for topical treatments other than the investigational product or products allowed per protocol in the study eye from Screening through the study Treatment Period
1. The study Treatment Period is defined as Study Days 1 through 53
2. Sufficient washout of prohibited therapies must occur prior to meeting eligibility criteria.
3. Anticipated use of therapeutic contact lenses or contact lens wear for refractive correction during the study Treatment Period in the study eye.
4. Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting, descemetocele, impending or perforation in the study eye at the time of Screening 1 or 2.
5. PCED at Screening 1 or 2 of \> 8 mm maximum linear measurement in any eye.
6. The central 3 mm of corneas contain PCED bilaterally at Screening 1 or 2.
7. Anticipated need for punctal occlusion of the study eye during the Treatment Period.
8. Presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct (e.g., progressive or degenerative corneal or retinal conditions, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).
9. Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to Day 1 (participation in a non-interventional observational study is permitted).
10. Intraocular surgery on the eligible eye(s) within 6 months prior to Screening 1, and any ophthalmic condition that may require surgery on the study eye during the Treatment Period. An exception to the preceding statement is allowed if, in the opinion of the Investigator, the ocular surgery is deemed the cause of the NK.
11. Corneal transplantation (i.e., keratoplasty) of the study eye. This includes full- or partial-thickness, or endothelial keratoplasty.
12. Subject who is pregnant or nursing.
13. Subject who is unwilling to comply with contraception requirements per-protocol (for subjects of childbearing potential).
14. Subject who is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator.
18 Years
ALL
No
Sponsors
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Krystal Biotech, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California Irvine
Irvine, California, United States
Azul Vision - California Eye Specialists Medical Group Inc.
Pasadena, California, United States
Midwest Cornea Associates
Carmel, Indiana, United States
Vance Thompson Vision
Alexandria, Minnesota, United States
Minnesota Eye Consultants
Minnetonka, Minnesota, United States
UPMC Vision Institute
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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UC Irvine Alpha Clinic
Role: primary
Kaci Taylor
Role: primary
Chris Bartizal, BS
Role: primary
Miranda Danielson
Role: primary
Bailee Larson
Role: backup
Allison Dreyer
Role: primary
UPMC Vision Institute Clinical Trials Team
Role: primary
Other Identifiers
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KB801-01
Identifier Type: -
Identifier Source: org_study_id