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

Not Applicable

Completed

• Conditions: Uveal Melanoma
• Interventions: Dietary Supplement: PLACEBO; Dietary Supplement: CITICOLINE

• Registration Number: NCT01338389
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Study Start: 2012-06-25
• Primary Completion: 2017-06-29
• Study Completion: 2017-06-29
• Status Verified: 2024-04
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• over 18 years old
• uveal melanoma with posterior marge located at less than 3 mm of optic papilla
• uveal melanoma treated with proton beam therapy with irradiation of optic head nerve
• visual acuity before proton beam therapy over 30 letters (with ETDRS test)

Exclusion Criteria

• antecedent of acute glaucoma with angle enclosure
• antecedent of chronical glaucoma with angle aperture
• antecedent of optic neuropathy optique of congenital, ischemic, inflammatory or other origins
• antecedent of neovascular glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PLACEBO	Daily oral administration of placebo
CITICOLINE	CITICOLINE	Daily oral administration of 800 mg citicoline

Primary Outcome Measures

Name	Time	Method
Occurrence and delay of occurrence of radiation optic neuropathy	Every 6 months	Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy

Secondary Outcome Measures

Name	Time	Method
Visual function assessment	Every 6 months	Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events

Trial Locations

Locations (2)

Ophtalmology Departement, St Roch Hopital, Nice University Hospital; 🇫🇷 Nice, France

CHU de NICE; 🇫🇷 Nice, France