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Compares treatment options for Neurotrophic Keratitis
Official title A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis
ClinicalTrials.gov ID: NCT06999733
What this study is testing
What is KB801?
KB801 is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for neurotrophic keratitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to...
- 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...
- PCED at Screening 1 must have a minimum of 1 mm of any linear measurement of defect.
You likely can't join if
- An active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the study eye as assessed by...
- Use of any prohibited therapies at Screening or anticipated need for topical treatments other than the investigational product or products allowed...
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
- 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 how well it works of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or...
- 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-treatment observational study is permitted).
- 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...
- Corneal transplantation (i.e., keratoplasty) of the study eye within the past 2 years or a history of multiple keratoplasty operations to the study eye regardless of timing. This includes full- or partial-thickness, or...
- Subject who is pregnant or nursing.
- Subject who is unwilling to comply with contraception requirements per-protocol (for people of childbearing potential).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Pasadena, California, United States
- Carmel, Indiana, United States
- Alexandria, Minnesota, United States
- Minnetonka, Minnesota, United States
- Town and Country, Missouri, United States
- Palisades Park, New Jersey, United States
- West Fargo, North Dakota, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Pasadena, California, United States; Carmel, Indiana, United States; Alexandria, Minnesota, United States; Minnetonka, Minnesota, United States; Town and Country, Missouri, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.