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

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01338389

Collaborator

DENSMORE pharmaceuticals (Other)

Enrollment

Locations

Arms

132.1

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma	Dietary Supplement: CITICOLINE Dietary Supplement: PLACEBO	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Actual Study Start Date :

Jun 25, 2012

Actual Primary Completion Date :

Jun 29, 2013

Anticipated Study Completion Date :

Jun 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Occurrence and delay of occurrence of radiation optic neuropathy [Every 6 months]
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 [Every 6 months]
Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU de NICE	Nice		France	06000
2	Ophtalmology Departement, St Roch Hopital, Nice University Hospital	Nice		France	06000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice
DENSMORE pharmaceuticals

Investigators

Principal Investigator: Stéphanie BAILLIF-GOSTOLI, MD, Ophtalmology department, Nice University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT01338389

Other Study ID Numbers:

11-PP-04

First Posted:

Apr 19, 2011

Last Update Posted:

Feb 7, 2018

Last Verified:

Feb 1, 2018

Additional relevant MeSH terms:

Melanoma

Uveal Neoplasms

Optic Nerve Diseases

Cytidine Diphosphate Choline

Study Results

No Results Posted as of Feb 7, 2018