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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01338389

Enrollment

Registered

2011-04-19

Start date

2012-06-25

Completion date

2017-06-29

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma

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.

Interventions

DIETARY_SUPPLEMENTCITICOLINE

Oral administration of CITICOLINE: Form: Powder for solution Dosage: 800mg per day duration: 5 years

DIETARY_SUPPLEMENTPLACEBO

Oral administration of placebo: Form: Powder for solution duration: 5 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026