Clinical trial NCT04422743: 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
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Keywords: Pattern electroretinogram
visual field
quality of life
citicoline 500 mg plus homotaurine 50 mg
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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
timeFrame: 4 months of therapy 2 months of wash out 4 months without adding therapy
measure: 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
timeFrame: 4 months of therapy 2 months of wash out 4 months without adding therapy
measure: 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
timeFrame: 4 months of therapy 2 months of wash out 4 months without adding therapy
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Gemma Caterina Maria Rossi
state: PV
city: Bari
country: Italy
facility: Dario Sisto
city: Brindisi
country: Italy
facility: Alberto Mavilio
city: Torino
country: Italy
facility: Teresa Rolle
Study officials:
affiliation: IRCCS Fondazione Policlinico San Matteo
name: gemma caterina m Rossi
role: STUDY_DIRECTOR
References: