The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1/2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.
Subjects will will be randomized 1:1 to receive KB801 or placebo (vehicle) topically to the study eye daily for 8 weeks. Subjects will return for a follow-up visit 2- weeks after finishing treatment to monitor for safety and durability of corneal healing. Safety follow-up visits will then occur every 3 months through approximately 1 year on study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
UC Irvine Alpha Clinic
Irvine, California, United States
NOT_YET_RECRUITINGAzul Vision - California Eye Specialists Medical Group Inc.
Pasadena, California, United States
RECRUITINGTo evaluate safety and tolerability of KB801 based upon assessment of adverse events (frequency, severity, relatedness).
Number of subjects with treatment related adverse events as assessed by CTCAE v5.
Time frame: 8 weeks
To evaluate the effect of KB801 on complete healing of the Persistent Corneal Epithelial Defect (PCED) in subjects with Stage 2 or Stage 3 NK
Proportion of subjects receiving KB801 exhibiting complete PCED closure at Week 8 compared to those receiving placebo.
Time frame: 8 weeks
To evaluate the effect of KB801 on complete healing of the PCED in subjects with Stage 2 or 3 NK
Proportion of subjects receiving KB801 with complete PCED closure at Weeks 4, 6 and 10 compared to those receiving placebo.
Time frame: 10 weeks
To evaluate the effect of KB801 on conventional healing of the PCED in subjects with Stage 2 or 3 NK
Proportion of subjects receiving KB801 achieving \<0.5-mm lesion size at Weeks 4, 6, 8, and 10 compared to those receiving placebo.
Time frame: 10 weeks
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Midwest Cornea Associates
Carmel, Indiana, United States
Vance Thompson Vision
Alexandria, Minnesota, United States
RECRUITINGMinnesota Eye Consultants
Minnetonka, Minnesota, United States
RECRUITINGSt. Louis Eye Institute
Town and Country, Missouri, United States
RECRUITINGMetropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States
RECRUITINGVance Thompson Vision
West Fargo, North Dakota, United States
RECRUITINGUPMC Vision Institute
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITING