Clinical trial NCT00404729: Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Optic Neuropathy, Ischemic
Visual Pathway Disorder
Optic Nerve
Neural Conduction
Keywords: Glaucoma
Optic Neuropathy, Ischemic
Visual Pathways,
Optic nerve
Neural conduction
Lead sponsor: Fondazione G.B. Bietti, IRCCS
Sponsor class: OTHER
First posted: 2006-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 (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)

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.

Eligibility criteria: Inclusion Criteria:

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;
* 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.

Exclusion Criteria:

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)

Primary outcomes:
measure: VEPs responses
timeFrame: 24 months
Secondary outcomes:
measure: Visual Field Defects
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione G.B. Bietti- IRCCS
city: Rome
country: Italy
facility: Fondazione G.B. Bietti-IRCCS
Study officials:
affiliation: Fondazione G.B. Bietti-IRCCS, Rome, Italy
name: Vincenzo Parisi, MD
role: STUDY_DIRECTOR
References:
citation: 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.