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

NCT01338389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • DENSMORE pharmaceuticals

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Stéphanie BAILLIF-GOSTOLI, MD · Ophtalmology department, Nice University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-25
Primary Completion
2017-06-29
Completion
2017-06-29

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338389 on ClinicalTrials.gov