Trial | NCT01338389  Report issue

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    citicoline ...

  • Study Participants

    21
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.
Study Started
Jun 25
2012
Primary Completion
Jun 29
2017
Study Completion
Jun 29
2017
Last Update
Nov 13
2023

Dietary Supplement CITICOLINE

Oral administration of CITICOLINE: Form: Powder for solution Dosage: 800mg per day duration: 5 years

Dietary Supplement PLACEBO

Oral administration of placebo: Form: Powder for solution duration: 5 years

CITICOLINE Experimental

Daily oral administration of 800 mg citicoline

Placebo Placebo Comparator

Daily oral administration of placebo

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
No Results Posted