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GlaucomaPhase 4NCT00404729

Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases

A Phase 4 study testing Citicoline in people with Glaucoma and Optic Neuropathy, Ischemic, run by Fondazione G.B. Bietti, IRCCS at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the management of glaucoma, as for as in other optic nerve diseases, an important goal of ophthalmologists is represented by the possibility of influencing visual function. In this regard, Parisi et al [Ophthalmology 1999; 106:1126-1134.] suggested the intramuscular treatment with Cytidine-5-diphosphocholine… Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
What is being tested?
Citicoline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesItaly
Study dates
28 Feb 2005to 30 Jul 2006
Phase
Phase 4
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 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Glaucoma Patients:
  • IOP > 23 mmHg and < 28 mmHg (average of the two highest readings of the daily curve, from 8:00 a.m. to 6:00 p.m., six independent readings, one every two hours) without medical treatment;
  • HFA with MD < - 2 dB; CPSD > +2 dB; fixation losses, false positive rate and false negative rate each less than 20%;
  • best corrected visual acuity of 20/20 or better;
  • one or more papillary signs on conventional color stereo-slides: the presence of a localized loss of neuroretinal rim (notch), thinning of the neuroretinal rim, generalized loss of optic rim tissue, optic disc excavation, vertical or horizontal cup/disc ratio greater than 0.5, cup-disc asymmetry between the two eyes greater than 0.2, peripapillary splinter hemorrhages;
  • refractive error (when present) between -1.00 and +1.00 spherical equivalent;
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  • no previous history or presence of any disease involving cornea, lens, macula or retina;
  • no previous history or presence of diabetes, optic neuritis, any disease involving the visual pathways;
  • pupil diameter > 3 mm without mydriatic or miotic drugs.
  • Patients with non-arteritic ischemic optic neuropathy:
  • IOP < 21 mmHg HFA with MD < - 2 dB; CPSD > +2 dB; fixation losses, false positive rate and false negative rate each less than 20%;
  • refractive error (when present) between -1.00 and +1.00 spherical equivalent;
  • no previous history or presence of any disease involving cornea, lens, macula or retina;
  • no previous history or presence of diabetes of any further disease involving the visual pathways;
  • pupil diameter > 3 mm without mydriatic or miotic drugs.

Who cannot join

  • All other condition that may influence Visual Evoked Potentials:
  • previous history or presence of any disease involving cornea, lens, macula or retina or optic nerve (i.e inflammatory diseases)

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Fondazione G.B. Bietti- IRCCS

    Rome, 00199

  • Fondazione G.B. Bietti-IRCCS

    Rome, 00199

Other trials in Italy

About this study

Official title: Phase 4 Study of Evaluation of Neural Conduction Along the Visual Pathways Before and After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases

In the management of glaucoma, as for as in other optic nerve diseases, an important goal of ophthalmologists is represented by the possibility of influencing visual function.

In this regard, Parisi et al [Ophthalmology 1999; 106:1126-1134.] suggested the intramuscular treatment with Cytidine-5-diphosphocholine (CDP-Choline or citicoline) to improve glaucomatous visual defects. In particular, recent studies reported the effects of citicoline on glaucomatous retinal and postretinal visual structures evaluated by electrophysiological examinations (PERG and VEP). It was observed that a 2-month period of treatment with citicoline may induce improvement in both ganglion cell function (PERGs with increase in amplitudes and shortening in times-to-peak) and in neural conduction along postretinal visual pathways (VEPs with increase in amplitudes and shortening in times-to-peak). The effects of citicoline on glaucomatous retinal and postretinal structures were not present 8 months after the end of treatment. However, performing several 2-month period of treatment with citicoline during a total period of 8 years, it was found a additional improvement of the glaucomatous retinal and postretinal impairment [Parisi V. Doc Ophthalmol. 2005 Jan;110:91-102). In this work, the investigators aimed to assess whether there similar visual function outcomes can be reached by the oral treatment with citicoline in patients affected by glaucomatous optic nerve disease as of as in other optic nerve diseases (i.e. non-arteritic ischemic optic neuropathy)

Read the detailed description

Participants: 30 patients with open-angle glaucoma (OAG) and 15 patients (mean age 64.6±3.3ys) with non-arteritic ischemic optic neuropathy (NION) were enrolled enrolled.

Ten OAG patients will be untreated (NT-AOG, 10 eyes), while 20 OAG patients (T-AOG, 20 eyes) and 15 NION patients (T-NION, 14 eyes) were treated with Citicoline (oral treatment:1600 mg/die per 60 days) (Cebrolux®, Tubilux, Italy).

Methods: In T-OAG, NT-OAG and T-NION patients, Visual Evoked Potentials (VEPs)were recorded in response to 15' checkerboard pattern stimuli.

VEPs were assessed 5 times during a total period of 360 days: at baseline conditions (0 day), after two different cycles of 60 days of treatment (days 0-60 and days 180-240), and after two different cycles of 120 days of wash out (days 60-180 and 240-360). In NT-AOG patients, VEPs were assessed at baseline conditions (0 day) and after 60, 180, 240 and 360 days.

Being tested
Citicoline
Keywords
Glaucoma, Optic Neuropathy, Ischemic, Visual Pathways,, Optic nerve, Neural conduction
Medical subject headings
Glaucoma, Optic Neuropathy, Ischemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiticolineDrug

    Ten OAG patients will be untreated (NT-AOG, 10 eyes), while 20 OAG patients (T-AOG, 20 eyes) and 15 NION patients (T-NION, 14 eyes) were treated with Citicoline (oral treatment:1600 mg/die per 60 days)

Study groups in NCT00404729
Study groupRoleWhat they receive
Citicoline treatmentOtherTen OAG patients will be untreated (NT-AOG, 10 eyes), while 20 OAG patients (T-AOG, 20 eyes) and 15 NION patients (T-NION, 14 eyes) were treated with Citicoline (oral treatment:1600 mg/die per 60 days)
Receives: Drug: Citicoline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VEPs responses

    P100 Implicit time and N75-P100 Amplitude

    Measured: 24 months

Secondary outcomes (1)

  1. Visual Field Defects

    Humphrey 24/1: Mean Deviation and Corrected Pattern Standard Deviation

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2006 (estimated)
  2. Study start28 Feb 2005
  3. Primary completion28 Feb 2006
  4. Study completion30 Jul 2006

Resources

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00404729
Sponsor's protocol ID
86216880
Other IDs
85356727
Status last verified
Feb 2021
First submitted
28 Nov 2006
Last updated
3 Feb 2021
Results posted
No

Publications

  • Parisi V. Electrophysiological assessment of glaucomatous visual dysfunction during treatment with cytidine-5'-diphosphocholine (citicoline): a study of 8 years of follow-up. Doc Ophthalmol. 2005 Jan;110(1):91-102. doi: 10.1007/s10633-005-7348-7.

    PubMed 16249960

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Citicoline in people with Glaucoma and Optic Neuropathy, Ischemic, run by Fondazione G.B. Bietti, IRCCS at 2 sites in Italy.

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 15 inclusion and 2 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 3 Feb 2021. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

VEPs responses (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00404729, which also lists 1 linked publication.

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 3 Feb 2021.

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