Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Eye Diseases

Rare Diseases

Melanoma

Optic Nerve Diseases

Uveal Neoplasms

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Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Eye Neoplasms

Uveal Diseases

Cranial Nerve Diseases

Intraocular Melanoma

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Nootropic Agents

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Vitamins

Cytidine Diphosphate Choline

Choline

Daily oral administration of 800 mg citicoline

Oral administration of CITICOLINE:

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

CITICOLINE

Oral administration of placebo:

Form: Powder for solution duration: 5 years

PLACEBO

Stéphanie BAILLIF-GOSTOLI, MD

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.

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

Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy

Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events

DENSMORE pharmaceuticals

Centre Hospitalier Universitaire de Nice

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy	NCT01338389	Uveal Melanoma	CITICOLINE PLACEBO	18 Years -	Centre Hospitalier Universitaire de Nice
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy	NCT01338389	Uveal Melanoma	CITICOLINE PLACEBO	18 Years -	Centre Hospitalier Universitaire de Nice
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy	NCT01338389	Uveal Melanoma	CITICOLINE PLACEBO	18 Years -	Centre Hospitalier Universitaire de Nice

Spots Global Cancer Trial Database for citicoline

Every month we try and update this database with for citicoline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for citicoline

Every month we try and update this database with for citicoline cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for citicoline cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.