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
  Purpose

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.


Condition Intervention
Uveal Melanoma
Dietary Supplement: CITICOLINE
Dietary Supplement: PLACEBO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CITICOLINE
Daily oral administration of 800 mg citicoline
Dietary Supplement: CITICOLINE

Oral administration of CITICOLINE:

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

Placebo Comparator: Placebo
Daily oral administration of placebo
Dietary Supplement: PLACEBO

Oral administration of placebo:

Form: Powder for solution duration: 5 years


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338389

Contacts
Contact: Stéphanie BAILLIF-GOSTOLI, MD baillif-gostoli.s@chu-nice.fr

Locations
France
Ophtalmology Departement, St Roch Hopital, Nice University Hospital Not yet recruiting
Nice, France, 06000
Contact: Delphine DEL CONT, CRA       delcont.d@chu-nice.fr   
Sub-Investigator: Jean-Pierre CAUJOLLE, MD         
CHU de NICE Recruiting
Nice, France, 06000
Contact: Stéphanie BAILLIF, M.D.       baillif-gostoli.s@chu-nice.fr   
Principal Investigator: Stéphanie BAILLIF-GOSTOLI, M.D.         
Sub-Investigator: Jean-Pierre CAUJOLLE, M.D.         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
DENSMORE pharmaceuticals
Investigators
Principal Investigator: Stéphanie BAILLIF-GOSTOLI, MD Ophtalmology department, Nice University Hospital
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01338389     History of Changes
Other Study ID Numbers: 11-PP-04
Study First Received: April 18, 2011
Last Updated: December 8, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Melanoma
Optic Nerve Diseases
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Eye Neoplasms
Neoplasms by Site
Uveal Diseases
Cytidine Diphosphate Choline
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014