Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases
|ClinicalTrials.gov Identifier: NCT00404729|
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : November 29, 2006
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, we 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)
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma Optic Neuropathy, Ischemic Visual Pathways, Optic Nerve Neural Conduction||Drug: Cytidine-5’-diphosphocholine (Citicoline)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2005|
|Estimated Study Completion Date :||July 2006|
- VEPs responses (P100 Implicit time and N75-P100 Amplitude)
- Visual Field Defects (Humphrey 24/1: Mean Deviation and Corrected Pattern Standard Deviation)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404729
|Fondazione G.B. Bietti- IRCCS|
|Rome, Italy, 00199|
|Fondazione G.B. Bietti-IRCCS|
|Rome, Italy, 00199|
|Study Director:||Vincenzo Parisi, MD||Fondazione G.B. Bietti-IRCCS, Rome, Italy|