Is NCT06999733 recruiting in Minnetonka, MN?

Yes, NCT06999733 is currently recruiting participants at its Minnetonka, MN location. This neurotrophic keratitis clinical trial is actively enrolling qualified participants.

How do I join the neurotrophic keratitis clinical trial in Minnetonka?

To join this clinical trial in Minnetonka, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Minnetonka clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neurotrophic Keratitis Clinical Trial in Minnetonka, MN

About This Neurotrophic Keratitis Study in Minnetonka

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.

Sponsor: Krystal Biotech, Inc.

Who Can Participate

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 a. Sufficient washout of prohibited therapies must occur prior to meeting eligibility criteria.

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 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).

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).

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.

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 endothelial keratoplasty.

Subject who is pregnant or nursing.

Subject who is unwilling to comply with contraception requirements per-protocol (for subjects 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Minnetonka?

Yes, this clinical trial (NCT06999733) has an active research site in Minnetonka, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neurotrophic Keratitis Treatment Options in Minnetonka, MN

If you're searching for neurotrophic keratitis treatment options in Minnetonka, MN, this clinical trial (NCT06999733) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Minnetonka research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced neurotrophic keratitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neurotrophic keratitis clinical trials near you to find additional studies recruiting in your area.

Neurotrophic Keratitis Clinical Trial in Minnetonka, MN

Expert Care in Minnetonka

IRB Approved

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