Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
Primary Purpose
Uveal Melanoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CITICOLINE
PLACEBO
Sponsored by
About this trial
This is an interventional prevention trial for Uveal Melanoma
Eligibility 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
Sites / Locations
- CHU de NICE
- Ophtalmology Departement, St Roch Hopital, Nice University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CITICOLINE
Placebo
Arm Description
Daily oral administration of 800 mg citicoline
Daily oral administration of placebo
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual function assessment
Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events
Full Information
NCT ID
NCT01338389
First Posted
April 18, 2011
Last Updated
February 6, 2018
Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
DENSMORE pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01338389
Brief Title
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2012 (Actual)
Primary Completion Date
June 29, 2013 (Actual)
Study Completion Date
June 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
DENSMORE pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CITICOLINE
Arm Type
Experimental
Arm Description
Daily oral administration of 800 mg citicoline
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily oral administration of placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
CITICOLINE
Intervention Description
Oral administration of CITICOLINE:
Form: Powder for solution Dosage: 800mg per day duration: 5 years
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
Oral administration of placebo:
Form: Powder for solution duration: 5 years
Primary Outcome Measure Information:
Title
Occurrence and delay of occurrence of radiation optic neuropathy
Description
Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy
Time Frame
Every 6 months
Secondary Outcome Measure Information:
Title
Visual function assessment
Description
Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events
Time Frame
Every 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie BAILLIF-GOSTOLI, MD
Organizational Affiliation
Ophtalmology department, Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de NICE
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Ophtalmology Departement, St Roch Hopital, Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
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