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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Centre Hospitalier Universitaire de Nice
Sponsor:
Collaborator:
DENSMORE pharmaceuticals
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01338389
First received: April 18, 2011
Last updated: December 8, 2011
Last verified: December 2011

April 18, 2011
December 8, 2011
December 2011
December 2018   (final data collection date for primary outcome measure)
Occurrence and delay of occurrence of radiation optic neuropathy [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy
Same as current
Complete list of historical versions of study NCT01338389 on ClinicalTrials.gov Archive Site
Visual function assessment [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events
Same as current
Not Provided
Not Provided
 
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Uveal Melanoma
  • 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

  • Experimental: CITICOLINE
    Daily oral administration of 800 mg citicoline
    Intervention: Dietary Supplement: CITICOLINE
  • Placebo Comparator: Placebo
    Daily oral administration of placebo
    Intervention: Dietary Supplement: PLACEBO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2018
December 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Stéphanie BAILLIF-GOSTOLI, MD baillif-gostoli.s@chu-nice.fr
France
 
NCT01338389
11-PP-04
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
DENSMORE pharmaceuticals
Principal Investigator: Stéphanie BAILLIF-GOSTOLI, MD Ophtalmology department, Nice University Hospital
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP