TerminatedNot Applicable

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

Stopped: due to covid 19 pandemy

Italy63 participantsStarted 2018-01-25

Plain-language 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.

Who can participate

Age range

40 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 acecl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 4 months of therapy 2 months of wash out 4 months without adding therapy

Trial details

NCT IDNCT04422743

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-11

View on ClinicalTrials.gov More Glaucoma trials