Multimodal Morpho-functional Study in Glaucoma Patients-Citicoline Oral Solution

Launched by FONDAZIONE G.B. BIETTI, IRCCS · Mar 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Citicoline, an oral solution, on patients with Primary Open Angle Glaucoma (OAG). The main goal is to see if taking Citicoline for 12 months can help improve the function of the nerves that carry visual information from the eye to the brain, since these nerves can be slower in people with OAG. The study will involve 60 participants who will be split into two groups: one group will receive Citicoline, while the other group will receive a placebo (a solution that looks the same but has no active ingredients). Importantly, the researchers conducting the tests won’t know which group each participant is in until after the trial, which helps ensure the results are fair and unbiased.

To be eligible for this trial, participants need to be between 20 and 70 years old and have a confirmed diagnosis of glaucoma, specifically with certain visual test results. They should also have good enough vision and controlled eye pressure with medication. However, individuals with recent eye surgeries, certain eye conditions, or other health issues may not qualify. Participants can expect to take the treatment daily for a year and will undergo various tests to monitor their eye and nerve health. This trial is a great opportunity for individuals looking to contribute to glaucoma research and potentially benefit from new treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 20 and 70 years old
• • Diagnosis of glaucoma. Glaucoma is defined as: glaucomatous damage of the CV (Humphrey 24-2 standard SITA with mean deviation between -6 and -25 dB) and glaucomatous appearance of the optic nerve
• • Visual acuity not less than 5/10
• • Eye pressure below 21 mmHg with the use of ocular hypotonizing drugs including sympathomimetics, beta-blockers, prostaglandins, beta-adrenergics, carbonic anhydrase inhibitors. Such drugs can be used both alone and in combination with each other.
• • Documented post-retinal nerve conduction delay through simultaneous recording of VEP and PERG showing an increase in RCT
• Exclusion Criteria:
• • Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.
• • Cataract or maculopathy
• • Argon laser trabeculoplasty (ALT) within the previous 6 months
• • Known hypersensitivity to the study product
• • Secondary causes of ocular hypertension, including systemic or topical use of steroids
• • Positive history of ocular or systemic diseases that could preclude enrollment in the study in the opinion of the investigators
• • Changes in systemic therapies that could compromise intraocular pressure values (beta-blockers, alpha and beta adrenergics, calcium inhibitors, ACE inhibitors) in the 30 days prior to enrollment
• • Ongoing therapy with vasoactive cerebral drugs, neurotrophic, lutein, zeaxanthin, retinal, acid, docosahexaenoic, Ubiquinone and / or its derivatives, Citicoline and / or its derivatives (possible previous treatment with Ubiquinone, L-Carnitine, Citicoline and / or its derivatives must have been suspended at least 6 months prior to inclusion in the study)
• • Pregnancy, breastfeeding
• • Diabetes
• • Systemic lupus erythematosus, rheumatoid arthritis, connectivitis
• • Concomitant use of anticoagulants and lithium