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

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Uveal Melanoma

Treatments: Dietary Supplement: PLACEBO; Dietary Supplement: CITICOLINE

Study type: Interventional

Funder types: Other

Identifiers

NCT01338389

11-PP-04

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

CITICOLINE

Experimental group

Description:

Daily oral administration of 800 mg citicoline

Treatment:

Dietary Supplement: CITICOLINE

Placebo

Placebo Comparator group

Description:

Daily oral administration of placebo

Treatment:

Dietary Supplement: PLACEBO