Glaucoma Clinical Trial
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
Verified date | November 2021 |
Source | IRCCS Policlinico S. Matteo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 63 |
Est. completion date | September 11, 2020 |
Est. primary completion date | September 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Dario Sisto | Bari | |
Italy | Alberto Mavilio | Brindisi | |
Italy | Gemma Caterina Maria Rossi | Pavia | PV |
Italy | Teresa Rolle | Torino |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Matteo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 4 months of therapy 2 months of wash out 4 months without adding therapy | |
Secondary | 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) | 4 months of therapy 2 months of wash out 4 months without adding therapy | |
Secondary | 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 | 4 months of therapy 2 months of wash out 4 months without adding therapy | |
Secondary | 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) | 4 months of therapy 2 months of wash out 4 months without adding therapy |
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