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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-25

Study Completion Date

2017-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Uveal Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CITICOLINE

Daily oral administration of 800 mg citicoline

Group Type EXPERIMENTAL

CITICOLINE

Intervention Type DIETARY_SUPPLEMENT

Oral administration of CITICOLINE:

Form: Powder for solution Dosage: 800mg per day duration: 5 years

Placebo

Daily oral administration of placebo

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DIETARY_SUPPLEMENT

Oral administration of placebo:

Form: Powder for solution duration: 5 years

Interventions

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CITICOLINE

Oral administration of CITICOLINE:

Form: Powder for solution Dosage: 800mg per day duration: 5 years

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

Oral administration of placebo:

Form: Powder for solution duration: 5 years

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No