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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Uveal Melanoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Occurrence and delay of occurrence of radiation optic neuropathy

Outcome Description:

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

Outcome Time Frame:

Every 6 months

Safety Issue:

No

Principal Investigator

Stéphanie BAILLIF-GOSTOLI, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ophtalmology department, Nice University Hospital

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

11-PP-04

NCT ID:

NCT01338389

Start Date:

December 2011

Completion Date:

December 2018

Related Keywords:

  • Uveal Melanoma
  • Melanoma
  • Optic Nerve Diseases
  • Uveal Neoplasms

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