Multicenter, Prospective, Randomized, Single Blind, Cross-Over Study on the Effect of a Fixed Combination of Citicoline 500 mg Plus Homotaurine 50 mg on Pattern Electroretinogram (PERG) in Patients With Open Angle Glaucoma on Well Controlled Intraocular Pressure

Abstract

PurposeTo evaluate the potential beneficial and synergistic effects of oral intake of a fixed combination of citicoline 500 mg plus homotaurine 50 mg (CIT/HOMO) on retinal ganglion cell (RGC) function in subjects with glaucoma using pattern electroretinogram (PERG) and to investigate the effects on visual field and quality of life.MethodsConsecutive patients with primary open-angle glaucoma with controlled IOP (<18 mmHg) receiving beta-blockers and prostaglandin analogs alone or as combination therapy (fixed or un-fixed); with stable disease (progression no more than −1 dB/year at the visual field MD); and an early to moderate visual field defect (MD < −12 dB) were randomized to: arm A. topical therapy + CIT/HOMO for 4 months, 2 months of wash out, 4 months of topical therapy alone; arm B. topical therapy alone for 4 months, topical therapy + CIT/HOMO for 4 months, 2 months of wash out. All patients underwent 4 visits: complete ocular examination, visual field, PERG and quality of life assessment (NEI-VFQ25) were performed at each visit.ResultsFifty-seven patients completed the study: 26 in group A and 31 in group B. At the end of the intake period, PERG's P50 and N95 waves recorded a greater amplitude. The increase was statistically significant in the inferior and superior P50 waves amplitude: 0.47 μV (95%CI, 0.02–0.93; p = 0.04) and 0.65 μV (95% CI, 0.16–1.13; p = 0.009), respectively, and in the inferior N95 wave amplitude 0.63 μV (95% CI, 0.22–1.04; p = 0.002). A significantly shorter peak time of 3.3 μV (95% CI, −6.01– −0.54; p = 0.01) was observed for the superior P50 wave only.ConclusionsDaily oral intake of the fixed combination CIT/HOMO for 4 months improved the function of inner retinal cells recorded by PERG in the inferior and in the superior quadrants, independently from IOP reduction. This interesting association could represent a valid option for practicing neuromodulation in patients with glaucoma to prevent disease progression.

Marine Natural Products Rescuing the Eye: A Narrative Review

“…In addition, another randomized, controlled, multicentric trial showed that daily oral administration of a fixed combination of citicoline and homotaurine for four months improved inner retinal cell function. Moreover, the visual field and the perception of quality of life were both positively affected by this improvement, which happened independently of IOP decrease [66] (Table 2). For this reason, homotaurine could be considered a potential neuroprotective compound that could reduce RGC loss thanks to its cytoprotective and neurotropic properties, helping in the management of glaucoma.…”

Optic Nerve Neuroprotection in Glaucoma: A Narrative Review

“…In another study, a randomized controlled multicentric trial demonstrated that the daily oral intake of the fixed combination of citicoline and homotaurine for 4 months led to an improvement in the function of inner retinal cells. This improvement occurred independently of intraocular pressure (IOP) reduction and positively impacted both the visual field and the perception of quality of life [27].…”

Citicolina: revisión farmacológica y clínica, actualización 2022

“…There is clinical evidence that citicoline improves visual acuity in patients with amblyopia [ 771 - 786 ], visual function in patients with glaucoma [ 787 - 814 ], in patients with non-arteritic ischemic optic neuropathy [ 815 , 816 ], and in early diabetic retinopathy [ 817 ].…”

“…Existen evidencias clínicas de que la citicolina mejora la agudeza visual en pacientes con ambliopía [ 771 - 786 ], la función visual en pacientes con glaucoma [ 787 - 814 ], en pacientes con neuropatía óptica isquémica no arterítica [ 815 , 816 ] y en la retinopatía diabética temprana [ 817 ].…”