Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neur… (NCT06411145) | Clinical Trial Compass
WithdrawnPhase 4
Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis
Stopped: The study was withdrawn prior to enrolling subjects due to realignment of strategic priorities.
0Started 2024-04-26
Plain-language summary
Primary Objective:
To assess the efficacy of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on overall corneal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16.
Secondary Objectives:
To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal thickness via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16.
To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal stromal reflectivity via AS-OCT in patients with stage 3 neurotrophic keratitis with respect to change from baseline at weeks 4, 8, and 16.
To assess the effects of cenegermin-bkbj (20 mcg/mL) ophthalmic solution on corneal sensitivity via Cochet-Bonnet aesthesiometer in the center of the lesion with respect to change from baseline at weeks 4, 8, and 16.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must be ≥18 years of age at time of screening.
. Patient must be stage 3 NK in the study eye defined by the Mackie Criteria at baseline (Appendix 4).
. Evidence of decreased corneal sensitivity in the study eye as measured by Cochet-Bonnet esthesiometry (≤4 cm in the center of the neurotrophic lesion) at baseline.
. Patients who have only one functional eye can be included if they meet all the criteria above and per the Investigator's discretion are proper candidates to designate the one functional eye as the study eye.
. Self-retaining amniotic membrane or any other amniotic topical product may be used prior to baseline visit (Visit 2) but should be removed or fully dissolved by the baseline measurements.
. Patients must have the ability and willingness to comply with study procedures and study product dosing as described in the protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in overall corneal thickness via AS-OCT from baseline to weeks 4, 8, and 16.
. Only patients who satisfy all informed consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign, and date the Institutional Review Board (IRB)-approved informed consent document before any study-related procedures are performed.
Exclusion criteria
. In the opinion of the Investigator, evidence or confirmed culture of an active ocular infection (bacterial, fungal, protozoal) in either eye at the time of screening or baseline.
. Evidence of a necrotizing herpetic ulcer in either eye at the time of screening or baseline.
. Active or severe corneal/ocular inflammation that requires continuous medical therapy throughout the duration of the treatment, including eyelid-based disorders such as severe MGD or blepharitis.
. Patients with posterior one-third corneal involvement or if posterior one-third of cornea becomes involved during the time between screening and baseline measurements, or at the Investigator's discretion is close to perforation.
. Patients who have excessive, pre-existing corneal opacification.
. Any of the following within 90 days of study enrollment:
. Treatment with Botox (botulinum toxin) injections in the study eye to induce pharmacologic blepharoptosis
. Treatment with intravenous chemotherapy for oncologic pathology