Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411145
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
A Prospective Multicenter Trial to Evaluate Efficacy and Safety of Cenegermin-bkbj 20 mcgmL Ophthalmic Solution on Corneal Thickness Via Anterior Segment Optical Coherence Tomography AS-OCT in Stage 3 Neurotrophic Keratitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGO
Brief Summary:
Primary Objective
To assess the efficacy of cenegermin-bkbj 20 mcgmL 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 mcgmL 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 mcgmL 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 mcgmL 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
To assess the efficacy of cenegermin-bkbj 20 mcgmL 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 mcgmL 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 mcgmL 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 mcgmL 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
Detailed Description:
This clinical study is a prospective open-label interventional multicenter study of 8 weeks of treatment with 8 weeks of follow-up after treatment to evaluate the efficacy of cenegermin-bkbj 20 mcgmL ophthalmic solution on corneal thickness and stromal clarity via AS-OCT in patients with stage 3 neurotrophic keratitis
The study will be a total of 16 weeks in duration an optional screening period of up to 2 weeks followed by an 8-week treatment period and an 8-week follow-up period At Visit 12 Baseline and Study Product Dispense Day -1 patients meeting the entry criteria for this study will be assigned to treatment with cenegermin-bkbj 20 mcgmL ophthalmic solution which will be known as Study Product beginning the morning following that visit or Day 0
After completion of the Treatment Period all patients who do not meet deterioration or no improvement criteria will continue to be followed for an additional 8-week Follow-Up Period
At any time during the study patients may be seen for additional unscheduled visits as deemed necessary by the Investigator
For patients who are prematurely discontinued from the study at any point an exit examination should be completed which represents the next data collection visit in the study timeline Once exited the Investigator should direct patients for further treatment as appropriate Patients in this study who are prematurely discontinued before completion of 8 weeks of treatment with cenegermin-bkbj 20 mcgmL ophthalmic solution will continue to be followed throughout the remainder of the study period if able
To minimize risk of bias all images will be assessed at an independent central reading center CRC The study site will acquire the images and perform a quality check however no analysis is required to be conducted by the Investigator on site
Visits list
1 Visit 11- Screening Visit Day -14 to -1
2 Visit 12- Baseline Visit and Study Product Dispensation Day -1
3 Treatment Period Weeks 1-8
4 Visit 2- Study Product Dispensation Day 14 3 days
5 Visit 3- Mid-Treatment Week 4 Evaluation and Study Product DispensationDay 28 3 days
6 Visit 4- Study Product Dispensation Visit Day 42 3 days
7 Visit 5- End-of-Treatment Week 8 Evaluation Day 56 3 days
8 Follow-Up Period Weeks 9-16
9 Visit 6- Final Follow-Up Week 16 Evaluation Day 112 3 days
The study will be a total of 16 weeks in duration an optional screening period of up to 2 weeks followed by an 8-week treatment period and an 8-week follow-up period At Visit 12 Baseline and Study Product Dispense Day -1 patients meeting the entry criteria for this study will be assigned to treatment with cenegermin-bkbj 20 mcgmL ophthalmic solution which will be known as Study Product beginning the morning following that visit or Day 0
After completion of the Treatment Period all patients who do not meet deterioration or no improvement criteria will continue to be followed for an additional 8-week Follow-Up Period
At any time during the study patients may be seen for additional unscheduled visits as deemed necessary by the Investigator
For patients who are prematurely discontinued from the study at any point an exit examination should be completed which represents the next data collection visit in the study timeline Once exited the Investigator should direct patients for further treatment as appropriate Patients in this study who are prematurely discontinued before completion of 8 weeks of treatment with cenegermin-bkbj 20 mcgmL ophthalmic solution will continue to be followed throughout the remainder of the study period if able
To minimize risk of bias all images will be assessed at an independent central reading center CRC The study site will acquire the images and perform a quality check however no analysis is required to be conducted by the Investigator on site
Visits list
1 Visit 11- Screening Visit Day -14 to -1
2 Visit 12- Baseline Visit and Study Product Dispensation Day -1
3 Treatment Period Weeks 1-8
4 Visit 2- Study Product Dispensation Day 14 3 days
5 Visit 3- Mid-Treatment Week 4 Evaluation and Study Product DispensationDay 28 3 days
6 Visit 4- Study Product Dispensation Visit Day 42 3 days
7 Visit 5- End-of-Treatment Week 8 Evaluation Day 56 3 days
8 Follow-Up Period Weeks 9-16
9 Visit 6- Final Follow-Up Week 16 Evaluation Day 112 3 days
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