NCT01338389

Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present. Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans. The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CITICOLINE	Oral administration of CITICOLINE: Form: Powder for solution Dosage: 800mg per day duration: 5 years
DIETARY_SUPPLEMENT	PLACEBO	Oral administration of placebo: Form: Powder for solution duration: 5 years

Timeline

• Start date: 2012-06-25
• Primary completion: 2017-06-29
• Completion: 2017-06-29
• First posted: 2011-04-19
• Last updated: 2025-02-24

Locations

2 sites across 1 country: France