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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 29, 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: CITICOLINE
    • Daily oral administration of 800 mg citicoline
  • Placebo Comparator: Placebo
    • Daily oral administration of placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nice
  • Collaborator
    • DENSMORE pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • St├ęphanie BAILLIF-GOSTOLI, MD, Principal Investigator, Ophtalmology department, Nice University Hospital

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