Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431113
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-21
Brief Title:
Effect of Fixed Combination Citicoline Homotaurine and Pyrroloquinoline Quinone on Pattern-electroretinogram in Glaucoma
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Effect of Fixed Combination Citicoline 500 mg Homotaurine 50 mg Pyrroloquinoline Quinone Neuprozin Mito on Pattern Electroretinogram in Controlled Open Angle Glaucoma PatientsA Multicenter Randomized Single Blind Cross-over Study
Status:
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:
None
Brief Summary:
The goal of this clinical trial is to examine the effect of the fixed combination Citicoline 500 mg Homotaurine 50 mg Pyrroloquinoline quinone PQQ disodium salt Neuprozin Mito on pattern electroretinogram PERG in patients with primary open angle glaucoma on well controlled intraocular pressure It will also learn about the safety of this fixed combination The main questions it aims to answer are
Does the fixed combination Citicoline 500 mg Homotaurine 50 mg Pyrroloquinoline quinone PQQ disodium salt Neuprozin Mito improve PERG amplitude andor latency Does the fixed combination act as neuromodulator in glaucoma patients based on electrophysiology Does the fixed combination improve quality of life of glaucoma patients Does the fixed combination have any effect on optical coherence tomography OCT
Researchers will compare the fixed combination Citicoline 500 mg Homotaurine 50 mg Pyrroloquinoline quinone PQQ disodium salt Neuprozin Mito to citicoline 800 mg to see if the fixed combination works better than citicoline alone as neuroprotective agent in glaucoma
Participants will
Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months
Visit the clinic at enrollment and once every 4 months at month 4 and at month 8 for checkups and tests visual field OCT PERG and quality of life questionnaire
Does the fixed combination Citicoline 500 mg Homotaurine 50 mg Pyrroloquinoline quinone PQQ disodium salt Neuprozin Mito improve PERG amplitude andor latency Does the fixed combination act as neuromodulator in glaucoma patients based on electrophysiology Does the fixed combination improve quality of life of glaucoma patients Does the fixed combination have any effect on optical coherence tomography OCT
Researchers will compare the fixed combination Citicoline 500 mg Homotaurine 50 mg Pyrroloquinoline quinone PQQ disodium salt Neuprozin Mito to citicoline 800 mg to see if the fixed combination works better than citicoline alone as neuroprotective agent in glaucoma
Participants will
Take the fixed combination or citicoline alone every day for 4 months After 4 months patients will be crossed over to the other treatment for 4 months
Visit the clinic at enrollment and once every 4 months at month 4 and at month 8 for checkups and tests visual field OCT PERG and quality of life questionnaire
Detailed Description:
Our general purpose is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone on retinal ganglion cells RGCs function in subjects with glaucoma by pattern electroretinogram
Primary objective To compare the effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone Neuprozin Mito - NPM a tablet a day on PERG examination p50 wave at four months of therapy compared to citicoline 800 mg alone Cebrolux - CIT as add-on to standard topical therapy
Secondary objectives
To compare the two treatments Neuprozin Mito - NPM vs citicoline - CIT - alone in terms of
visual acuity over time
visual field changes over time if any
Quality of Life perception National Eye Institute-Visual function questionnaire 25 item -NEI VFQ25 questionnaire over time
optical coherence tomography - OCT- changes over time if any
Safety Incidence of adverse events
Study design and planning Multicentric randomized 2-sequence 2-period 2-treatment crossover study with blind outcome assessor
Centers
1 Azienda Ospedaliera Universitaria Federico II UOC Oculistica Napoli
2 Clinica Oculistica dellUniversità degli Studi di Pavia IRCCS Policlinico San Matteo Foundation Pavia
3 Dipartimento di Scienze Medico-Chirurgiche e Medicina Traslazionale Università di Roma Sapienza Roma
Study duration Study duration 14 months Enrolment period 6 months Minimum Follow-up 8 months Total sample size 40 patients
Primary objective To compare the effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg plus Pyrroloquinoline quinone Neuprozin Mito - NPM a tablet a day on PERG examination p50 wave at four months of therapy compared to citicoline 800 mg alone Cebrolux - CIT as add-on to standard topical therapy
Secondary objectives
To compare the two treatments Neuprozin Mito - NPM vs citicoline - CIT - alone in terms of
visual acuity over time
visual field changes over time if any
Quality of Life perception National Eye Institute-Visual function questionnaire 25 item -NEI VFQ25 questionnaire over time
optical coherence tomography - OCT- changes over time if any
Safety Incidence of adverse events
Study design and planning Multicentric randomized 2-sequence 2-period 2-treatment crossover study with blind outcome assessor
Centers
1 Azienda Ospedaliera Universitaria Federico II UOC Oculistica Napoli
2 Clinica Oculistica dellUniversità degli Studi di Pavia IRCCS Policlinico San Matteo Foundation Pavia
3 Dipartimento di Scienze Medico-Chirurgiche e Medicina Traslazionale Università di Roma Sapienza Roma
Study duration Study duration 14 months Enrolment period 6 months Minimum Follow-up 8 months Total sample size 40 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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