Uveal MelanomaNCT01338389
Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
A study testing CITICOLINE in people with Uveal Melanoma, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- CITICOLINE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jun 2012to 29 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de NICE
Nice, 06000
Ophtalmology Departement, St Roch Hopital, Nice University Hospital
Nice, 06000
About this study
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
- Uveal Melanoma
- Being tested
- CITICOLINE, PLACEBO
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CITICOLINEDietary supplement
Oral administration of CITICOLINE:
Form: Powder for solution Dosage: 800mg per day duration: 5 years
PLACEBODietary supplement
Oral administration of placebo:
Form: Powder for solution duration: 5 years
| Study group | Role | What they receive |
|---|---|---|
| CITICOLINE | Experimental | Daily oral administration of 800 mg citicoline Receives: Dietary Supplement: CITICOLINE |
| Placebo | Placebo comparator | Daily oral administration of placebo Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and delay of occurrence of radiation optic neuropathy
Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy
Measured: Every 6 months
Secondary outcomes (1)
Visual function assessment
Best corrected visual acuity (ETDRS) ; Pattern ERG ; Visual Evoked potentials; adverse events
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study start25 Jun 2012
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- DENSMORE pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Stéphanie BAILLIF-GOSTOLI, MD, Principal investigator, Ophtalmology department, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338389
- Sponsor's protocol ID
- 11-PP-04
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2011
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01338389
- Acronym / sponsor ID
- 11-PP-04
- Conditions
- Uveal Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- DENSMORE pharmaceuticals
- Study start
- 25 Jun 2012 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CITICOLINE | Experimental | Dietary Supplement: CITICOLINEDaily oral administration of 800 mg citicoline |
| Placebo | Placebo comparator | Dietary Supplement: PLACEBODaily oral administration of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CITICOLINEOral administration of CITICOLINE: Form: Powder for solution Dosage: 800mg per day duration: 5 years | Dietary supplement | CITICOLINE |
| PLACEBOOral administration of placebo: Form: Powder for solution duration: 5 years | Dietary supplement | Placebo |
Primary outcome
Occurrence and delay of occurrence of radiation optic neuropathy
Time frame: Every 6 months
Occurrence and delay of occurrence of radiation optic neuropathy in patients treated for uveal melanomas with proton beam therapy
1 secondary outcome
Visual function assessment
Time frame: Every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie BAILLIF-GOSTOLI, MD principal investigator
Ophtalmology department, Nice University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CITICOLINE in people with Uveal Melanoma, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and delay of occurrence of radiation optic neuropathy (time frame: Every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.