Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05700864
Status:
WITHDRAWN
Last Update Posted:
2023-01-26
First Post:
2022-09-06
Brief Title:
NGF Treatment for Patients With Neuropathic Corneal Pain
Sponsor:
Tufts Medical Center
Organization:
Tufts Medical Center
Study Overview
Official Title:
Assessing the Efficacy of Recombinant Human Nerve Growth Factor rhNGF Treatment in Patients With Neuropathic Corneal Pain NCP
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding of study was withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective single center interventional open-label single arm non-randomized trial seeks to investigate the efficacy of Oxervate cenergermin 0002 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 -12 until the baselineVisit 2 At the end of the washout period day -8 to day -12 participants meeting the entry criteria for this study will be assigned to receive the Oxervate at 4timesdaily 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 4timesdaily 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 partialno-improvement participants will be instructed to begin an increased dosing regimen of 6timesdaily If at any point during the intervention period ocular painirritation 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 dropsday of preservative free artificial tears will be clearly documented in a participants diary and in the CRF
At Week 1 participants will be queried for adverse events If the participant reports side effects while on 4timesdaily 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 partialno-improvement participants will be instructed to begin an increased dosing regimen of 6timesdaily If at any point during the intervention period ocular painirritation 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 dropsday of preservative free artificial tears will be clearly documented in a participants diary and in the CRF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None