NCT05700864

NGF Treatment for Patients With Neuropathic Corneal Pain

Assessing the Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Treatment in Patients With Neuropathic Corneal Pain (NCP)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. All patients will be evaluated for clinical symptoms and signs of NCP, corneal staining and nerve regeneration (by IVCM) at Baseline (Visit 2) through the end of study (16 weeks post treatment).

Detailed description

During the screening (Visit 1 / Day -8) all procedures for inclusion will be performed. From the day of screening the participants will stop any kind of further previous ocular treatment regime, except commercially available preservative free artificial tears provided by Sponsor for 7 days and 9 days as maximum (day -8 to day -1+2) until the baseline(Visit 2) . At the end of the washout period (day -8 to day -1+2), participants meeting the entry criteria for this study will be assigned to receive the Oxervate® at 4times/daily dosing in both eyes for 4 weeks. At Week 1, participants will be queried for adverse events. If the participant reports side effects while on 4times/daily dosing, subjects will be instructed to begin a modified dosing regimen: 4 times daily for 3 days, then 1 day off dosing. At Week 4, participants will be evaluated for clinically significant changes. If resolution of NCP or improvement is observed, Oxervate® will be discontinued. If there is partial/no-improvement, participants will be instructed to begin an increased dosing regimen of 6times/daily. If at any point during the intervention period ocular pain/irritation is worsened for a prolonged period, Oxervate® intervention will be discontinued. During the 8 weeks of intervention, only the administration of Oxervate® is allowed. Nevertheless, if strictly needed, the participant can take preservative free artificial tears (provided by Sponsor). The use (n° drops/day) of preservative free artificial tears will be clearly documented in a participant's diary and in the CRF.

Conditions

• Corneal Disease
• Neuropathy

Interventions

Type	Name	Description
DRUG	Cenegermin-Bkbj	Cenegermin-bkbj ophthalmic solution administered as one drop in both eyes every 3 hours 4 times daily for 4 weeks

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-01-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study