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TerminatedNCT04422743Updated May 1, 2025

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

An interventional study of Citicoline 500 mg plus Homotaurine 50 mg in Glaucoma, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Terminated at 4 sites in Italy. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-01.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment

Why this study was terminated
due to covid 19 pandemy

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Jan 2018, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Glaucoma

Keywords

  • Pattern electroretinogram
  • visual field
  • quality of life
  • citicoline 500 mg plus homotaurine 50 mg
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 63 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

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

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

    Dietary Supplement: Citicoline 500 mg plus Homotaurine 50 mg

  • No intervention
    standard of care

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

Interventions

  • Dietary supplementCiticoline 500 mg plus Homotaurine 50 mg

    Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy

    Also known as: CIT/HOMO, Neuprozin®

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy

Secondary outcomes

  1. 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)

    Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy

  2. 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

    Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy

  3. 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)

    Time frame: 4 months of therapy 2 months of wash out 4 months without adding therapy

07

Study locations

4 sites
  • Gemma Caterina Maria Rossi
    Pavia, PV 27100, Italy
  • Dario Sisto
    Bari, 70121, Italy
  • Alberto Mavilio
    Brindisi, 72100, Italy
  • Teresa Rolle
    Torino, 10121, Italy
08

References and documents

Individual participant data

Plan to share: Yes — data will be published on peer review journal

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04422743
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible party
Gemma Caterina Maria Rossi (Principal Investigator, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Jun 9, 2020
Start date
Jan 25, 2018
Primary completion
Sep 11, 2020
Completion
Sep 11, 2020
Last update
May 1, 2025

Study contacts

gemma caterina m Rossi
study director · IRCCS Fondazione Policlinico San Matteo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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