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

Gemma Caterina Maria Rossi; Teresa Rolle; Annalisa De Silvestri; Dario Sisto; Alberto Mavilio; Alessandra Venera Mirabile; Alessia Paviglianiti; Beatrice Strano; Erica Picasso; Gian Maria Pasinetti; Giovanni Milano; Giulio Ruberto

doi:10.3389/fmed.2022.882335

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

Front Med (Lausanne). 2022 Apr 29:9:882335. doi: 10.3389/fmed.2022.882335. eCollection 2022.

Affiliations

¹ Department of Surgical Sciences, University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
² Department of Surgical Sciences, School of Medicine, University of Turin, Turin, Italy.
³ Clinical Epidemiology and Biometric Unit, Scientific Direction, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
⁴ Department of Neuroscience, Eye Clinic, Aldo Moro University of Bari, Bari, Italy.
⁵ ASL of Brindisi, Brindisi, Italy.
⁶ Eye Unit, Istituto Beato Palazzolo, Bergamo, Italy.

Abstract

Purpose: To 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.

Methods: Consecutive 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.

Results: Fifty-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.

Conclusions: Daily 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.

Keywords: Retimax; citicoline; glaucoma; homotaurine; neuroprotection; pattern electroretinogram (PERG); quality of life; visual field.