Can Treatment With Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial

Abstract

Precis: Citicoline eyedrops in patients with progressing glaucoma. Purpose: This study aimed to test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP)-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mm Hg or less. Design: This was a randomized, double-masked, placebo-controlled, multicenter 3-year study. Outcomes: The outcomes studied were difference in the visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression and difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years. Methods: Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least −0.5 dB/y in the 2 years before enrollment despite IOP ≤18 mm Hg were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent a visual field examination with 24-2 and 10-2 strategies and RNFL assessment. Analysis of variance and linear models were used to test the differences between groups. Results: Eighty patients were randomized in the trial. The mean 3-year rates of progression were −1.03 (2.14) dB in the citicoline group and −1.92 (2.23) dB in the placebo group ( P =0.07) for 24-2 MD and −0.41 (3.45) dB in the citicoline group and −2.22 (3.63) dB in the placebo group ( P =0.02) for 10-2 MD. On average, patients receiving citicoline eyedrops lost 1.86 μm of RNFL in 3 years, versus 2.99 μm in the placebo group ( P =0.02). Conclusions: Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18 mm Hg.

Citicoline in Ophthalmological Neurodegenerative Disease: A Comprehensive Review

“…More recently, a randomized clinical trial (prospective, multicentric, and placebo-controlled study) was performed using citicoline 2% eye drops (OMK1 ® ) on OAG patients with an MD ranging from −2 to −15 dB [ 74 ]. In this study, 80 patients were enrolled with a mild RoP in the two years before the baseline visit (−0.77 dB/year), despite a good IOP control.…”

“…In addition to psychophysical evidence, the studies conducted by Lanza et al [ 71 ] and Rossetti et al [ 74 ] also evaluated the RNFL thinning on optic nerve head by Optical Coherence Tomography (OCT) examination.…”

Natural Products: Evidence for Neuroprotection to Be Exploited in Glaucoma

“…Furthermore, topical treatment with citicoline eyedrops in open angle glaucoma patients was effective in enhancing PERG amplitude and improving VEP parameters [ 171 ]. Last, the results of a pilot randomized placebo-controlled clinical trial on 80 patients with mild to moderate OAG (primary or PEX) receiving citicoline eyedrops or placebo for 3 years suggest that citicoline might reduce disease progression in patients with IOP < 18 mmHg [ 172 ].…”

Bedeutung von Citicolin bei der Glaukomerkrankung

“…nach 2 Jahren zu einer signifikanten Reduktion der Gesichtsfeldprogression und der Abnahme in der retinalen Nervenfaserschicht in der optischen Kohärenztomographie (OCT) kommt [25]. In einer zweiten randomisierten doppelmaskierten placebokontrollierten multizentrischen Studie über 3 Jahre wurde gezeigt, dass Citicolin zu einer signifikanten Reduktion der funktionellen (Weiß-Weiß-Perimetrie) und morphologischen (Dicke der retinalen Nervenfaserschicht in der OCT) Progression führte [43]. In diese Studie wurden leicht-bis mittelgradige Offenwinkelglaukome eingeschlossen, die bei einem IOD unter 18 mm Hg in den 2 Jahren vor Studienbeginn eine Progression in der Perimetrie (MD) von bis 0,5 dB/Jahr aufwiesen.…”