Skip to main content
OpenTrials
Completed

NCT Number: NCT01338389

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NICE, Nice, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citicoline

Dietary Supplement

Oral administration of CITICOLINE:

Form: Powder for solution Dosage: 800mg per day duration: 5 years

Placebo

Dietary Supplement

Oral administration of placebo:

Form: Powder for solution duration: 5 years

Primary outcomes

  1. Occurrence and delay of occurrence of radiation optic neuropathy

    Time frame: Every 6 months

    Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy

Secondary outcomes

  1. Visual function assessment

    Time frame: Every 6 months

    Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • DENSMORE pharmaceuticals

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2011
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.