A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis (NCT06999733) | Clinical Trial Compass
RecruitingPhase 1/2
A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
United States60 participantsStarted 2025-07-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.
✓. Aged ≥ 18 years at the time of informed consent.
✓. Diagnosis of Stage 2 or Stage 3 NK, as defined by the Mackie criteria.
✓. Persistent corneal epithelial defect (PCED) between Screening 1 and Screening 2 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).
✓. PCED at Screening 1 must have a minimum of 1 mm of any linear measurement of defect.
✓. A negative pregnancy test at Screening 1 and Day 1 for women of child-bearing potential.
Exclusion criteria
✕. An active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the study eye as assessed by Investigator at Screening 1 or 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
✕. Anticipated use of therapeutic contact lenses or contact lens wear for refractive correction during the study Treatment Period in the study eye.
✕. 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.
What they're measuring
1
To evaluate safety and tolerability of KB801 based upon assessment of adverse events (frequency, severity, relatedness).
Timeframe: 8 weeks
2
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
✕. PCED at Screening 1 or 2 of \> 8 mm maximum linear measurement in any eye.
✕. The central 3 mm of corneas contain PCED bilaterally at Screening 1 or 2.
✕. Anticipated need for punctal occlusion of the study eye during the Treatment Period.
✕. 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).