Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02855450
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2016-08-01
Brief Title:
Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma
Sponsor:
Dompé Farmaceutici SpA
Organization:
Dompé Farmaceutici SpA
Study Overview
Official Title:
An 8 Week Phase Ib Monocentric Randomized Double-masked Parallel Groups Study With a 24 Week Follow-up to Evaluate Safety and Potential Efficacy of a 180 μgml rhNGF Eye Drops Solution Vs Vehicle in Patients With Glaucoma
Status:
COMPLETED
Status Verified Date:
2020-11
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:
NGF-Glaucoma
Brief Summary:
The primary objective of the study is to assess the safety and tolerability of a 180μgml TID dose regimen of recombinant human nerve growth factor rhNGF eye drop solution administered over 8 weeks versus a vehicle control in patients with progressive primary open-angle glaucoma despite IOP control
The secondary objectives are to measure the changes in BCDVA visual field ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography The secondary outcomes will be examined at 1 4 and 8 weeks of therapy and at 4 and 24 weeks after cessation of therapy Week 12 visit and Week 32 visit and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment
The secondary objectives are to measure the changes in BCDVA visual field ERG and structural changes in ganglion cell layer and nerve fiber layer thickness measured by optical coherence tomography The secondary outcomes will be examined at 1 4 and 8 weeks of therapy and at 4 and 24 weeks after cessation of therapy Week 12 visit and Week 32 visit and will include functional assessments to investigate evidence of a persistent biological effect after discontinuation of the study treatment
Detailed Description:
This is an 8 Week phase Ib monocentric randomized double-masked vehicle controlled parallel groups study with a 24 Week follow-up period to evaluate the safety and potential efficacy of a 180 μgml recombinant human nerve growth factor rhNGF eye drops solution versus vehicle in 60 study participants with chronic primary open angle glaucoma
Participants may qualify with either progressive optic neuropathy despite maximal current therapy ie IOP reduction or with stabilized IOP but diminished vision central or peripheral
Participants with a qualifying eye will be randomized 21 to topical recombinant human nerve growth factor rhNGF therapy or vehicle placebo control Examinations for safety and efficacy will occur one week following initiation of therapy and at 4 8 12 and 32 weeks
All participants in either arm will be followed clinically at 4 weeks after cessation of therapy
Participants may qualify with either progressive optic neuropathy despite maximal current therapy ie IOP reduction or with stabilized IOP but diminished vision central or peripheral
Participants with a qualifying eye will be randomized 21 to topical recombinant human nerve growth factor rhNGF therapy or vehicle placebo control Examinations for safety and efficacy will occur one week following initiation of therapy and at 4 8 12 and 32 weeks
All participants in either arm will be followed clinically at 4 weeks after cessation of therapy
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