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Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma

Primary Purpose

Glaucoma

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Citicoline 500 mg plus Homotaurine 50 mg
Sponsored by
IRCCS Policlinico S. Matteo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Pattern electroretinogram, visual field, quality of life, citicoline 500 mg plus homotaurine 50 mg

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 40 and 75 years;
  • diagnosis of primary OAG (POAG) from, at least, 3 years;
  • visual acuity > 0.7 (7/10) decimals;
  • refractive error < 5 D (spheric) and < 2D (toric);
  • transparent diopter means (cornea and lens);
  • controlled IOP (<18 mmHg, morning value) with beta-blockers and prostaglandin analogues as monotherapy or as associative therapy (fixed or unfixed);
  • stable IOP<18 mmHg in the last 2 years;
  • stable and unchanged topical therapy in the last 6 months;
  • stable disease in the last 2 years (no more than -1 dB/year at MD of visual field);
  • at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm -SITA- Standard) per year in the last 2 years;
  • early to moderate visual field defect (MD <12 dB);
  • electrophysiological (PERG) parameters alterations similar to glaucomatous pathology;
  • written consent to participate to study procedures and data utilization in an anonymous form

Exclusion Criteria:

  • ocular hypertension with normal optic nerve and visual field; angle closure glaucoma;
  • congenital glaucoma; secondary glaucoma; normal tension glaucoma;
  • history of recurrent uveitis/scleritis/herpes infection;
  • pregnancy and breastfeeding;
  • contraindication to Citicoline and/or Homotaurine
  • contraindication to beta-blockers and prostaglandine analogues
  • topical therapy with Brimonidine monotherapy or fixed combination (with timolol or brinzolamide)
  • topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment
  • systemic therapies affecting patients' performance in visual field examination (sedatives);
  • glaucomatous scotomas within 10 degree from fixation
  • any condition limiting the patient's ability to participate in the study;
  • other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy;
  • other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders;
  • cerebral ischemia in the last 2 years
  • any change in topical therapy in the 6 months prior to enrollment or during the study period concomitant participation to another clinical trial
  • any previous filtering and/or retinal surgery;
  • cataract surgery in the last 6 months;
  • any previous laser treatment for glaucoma in the last 5 years

Sites / Locations

  • Gemma Caterina Maria Rossi
  • Dario Sisto
  • Alberto Mavilio
  • Teresa Rolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

standard of care + citicoline plus homotaurine (CIT/HOMO)

standard of care

Arm Description

CIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication)

only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months

Outcomes

Primary Outcome Measures

To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
changes in amplitude (microVolt)

Secondary Outcome Measures

To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
changes in visual acuity (decimals)
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)

Full Information

First Posted
June 4, 2020
Last Updated
November 11, 2021
Sponsor
IRCCS Policlinico S. Matteo
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1. Study Identification

Unique Protocol Identification Number
NCT04422743
Brief Title
Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma
Official Title
Effect of the Fixed Combination Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram in Well Controlled Primary Open Angle Glaucoma: A Multicenter, Prospective, Randomized, Single Blind, Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
due to covid 19 pandemy
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
September 11, 2020 (Actual)
Study Completion Date
September 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
the general purpose of the study is to evaluate the potential beneficial effects of supplementation of a fixed combination of Citicoline 500 mg plus Homotaurine 50 mg on retinal ganglion cells (RGCs) function in subjects with glaucoma by pattern electroretinogram.
Detailed Description
Secondary objectives are to assess effects on visual acuity, visual field changes, Quality of Life perception (NEI VFQ25 questionnaire), and safety (Incidence of adverse events)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Pattern electroretinogram, visual field, quality of life, citicoline 500 mg plus homotaurine 50 mg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard of care + citicoline plus homotaurine (CIT/HOMO)
Arm Type
Experimental
Arm Description
CIT/HOMO was supplemented for 4 months to the standard of care (SOC, i.e. topical intraocular pressure, IOP, lowering medication)
Arm Title
standard of care
Arm Type
No Intervention
Arm Description
only standard of care (SOC, i.e. topical IOP lowering medication) for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Citicoline 500 mg plus Homotaurine 50 mg
Other Intervention Name(s)
CIT/HOMO, Neuprozin®
Intervention Description
Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy
Primary Outcome Measure Information:
Title
To assess effects of adding the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP), one tablet a day, on PERG examination at four months of therapy, compared to standard of care alone, as add-on to standard therapy
Description
changes in amplitude (microVolt)
Time Frame
4 months of therapy 2 months of wash out 4 months without adding therapy
Secondary Outcome Measure Information:
Title
To assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual acuity
Description
changes in visual acuity (decimals)
Time Frame
4 months of therapy 2 months of wash out 4 months without adding therapy
Title
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on visual field
Description
changes in mean deviation (deciBell-dB) and in pattern standard deviation (deciBell-dB) of visual field parameters
Time Frame
4 months of therapy 2 months of wash out 4 months without adding therapy
Title
to assess effects of one tablet a day of the fixed combination of Citicoline 500 mg plus Homotaurine 50 mg (Neuprozin® - NP) on quality of life
Description
changes in the total mean score and in the subscales of the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) (scores are presented as a number, higher numbers reflect higher QL)
Time Frame
4 months of therapy 2 months of wash out 4 months without adding therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 40 and 75 years; diagnosis of primary OAG (POAG) from, at least, 3 years; visual acuity > 0.7 (7/10) decimals; refractive error < 5 D (spheric) and < 2D (toric); transparent diopter means (cornea and lens); controlled IOP (<18 mmHg, morning value) with beta-blockers and prostaglandin analogues as monotherapy or as associative therapy (fixed or unfixed); stable IOP<18 mmHg in the last 2 years; stable and unchanged topical therapy in the last 6 months; stable disease in the last 2 years (no more than -1 dB/year at MD of visual field); at least two reliable visual fields (Humphrey 24-2 Swedish interactive threshold algorithm -SITA- Standard) per year in the last 2 years; early to moderate visual field defect (MD <12 dB); electrophysiological (PERG) parameters alterations similar to glaucomatous pathology; written consent to participate to study procedures and data utilization in an anonymous form Exclusion Criteria: ocular hypertension with normal optic nerve and visual field; angle closure glaucoma; congenital glaucoma; secondary glaucoma; normal tension glaucoma; history of recurrent uveitis/scleritis/herpes infection; pregnancy and breastfeeding; contraindication to Citicoline and/or Homotaurine contraindication to beta-blockers and prostaglandine analogues topical therapy with Brimonidine monotherapy or fixed combination (with timolol or brinzolamide) topical therapy with pilocarpine and aceclidine, monotherapy or fixed combination systemic or topical treatment with another neuroprotective agent in the last 4 months prior to enrollment systemic therapies affecting patients' performance in visual field examination (sedatives); glaucomatous scotomas within 10 degree from fixation any condition limiting the patient's ability to participate in the study; other ocular causes of visual field and PERG changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion, diabetic retinopathy; other systemic causes of visual field and PERG changes such as neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, ALS, MS) or pituitary disorders; cerebral ischemia in the last 2 years any change in topical therapy in the 6 months prior to enrollment or during the study period concomitant participation to another clinical trial any previous filtering and/or retinal surgery; cataract surgery in the last 6 months; any previous laser treatment for glaucoma in the last 5 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gemma caterina m Rossi
Organizational Affiliation
IRCCS Fondazione Policlinico San Matteo
Official's Role
Study Director
Facility Information:
Facility Name
Gemma Caterina Maria Rossi
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Dario Sisto
City
Bari
ZIP/Postal Code
70121
Country
Italy
Facility Name
Alberto Mavilio
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Teresa Rolle
City
Torino
ZIP/Postal Code
10121
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be published on peer review journal
IPD Sharing Time Frame
upon publication
IPD Sharing Access Criteria
actually not available

Learn more about this trial

Effect of Citicoline/Homotaurine on PERG in Primary Open Angle Glaucoma

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