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

NCT01338389 | Completed

• 1 other identifier: 11-PP-04
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

• Occurrence and delay of occurrence of radiation optic neuropathy

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

  Every 6 months

Secondary Outcomes (1)

• Visual function assessment

  Every 6 months

Study Arms (2)

CITICOLINE

EXPERIMENTAL

Daily oral administration of 800 mg citicoline

Dietary Supplement: CITICOLINE

Placebo

PLACEBO COMPARATOR

Daily oral administration of placebo

Dietary Supplement: PLACEBO

Interventions

CITICOLINE DIETARY_SUPPLEMENT

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

CITICOLINE

PLACEBO DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• DENSMORE pharmaceuticals: collaborator

Study Sites (2)

CHU de NICE

Nice, 06000, France

Location

Ophtalmology Departement, St Roch Hopital, Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Stéphanie BAILLIF-GOSTOLI, MD

  Ophtalmology department, Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: April 19, 2011
• Study Start: June 25, 2012
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: February 24, 2025

Record last verified: 2024-04

Locations

FR (2)