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

Uveal Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338389
• Other study ID #: 11-PP-04
• Status: Completed
• Phase: N/A
• Start date: June 25, 2012
• Est. completion date: June 29, 2017

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Optic Nerve Diseases
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Dietary Supplement:
• CITICOLINE
Oral administration of CITICOLINE: Form: Powder for solution Dosage: 800mg per day duration: 5 years
• PLACEBO
Oral administration of placebo: Form: Powder for solution duration: 5 years

Locations

Country	Name	City	State
France	CHU de NICE	Nice
France	Ophtalmology Departement, St Roch Hopital, Nice University Hospital	Nice

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	DENSMORE pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual function assessment	Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events	Every 6 months