Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00404729
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2006-11-28
Brief Title:
Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases
Sponsor:
Fondazione GB Bietti IRCCS
Organization:
Fondazione GB Bietti IRCCS
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1061126-1134 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 Jan11091-102 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 ie non-arteritic ischemic optic neuropathy
In this regard Parisi et al Ophthalmology 1999 1061126-1134 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 Jan11091-102 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 ie non-arteritic ischemic optic neuropathy
Detailed Description:
Participants 30 patients with open-angle glaucoma OAG and 15 patients mean age 64633ys 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 treatment1600 mgdie per 60 days Cebrolux Tubilux Italy
Methods In T-OAG NT-OAG and T-NION patients Visual Evoked Potentials VEPswere 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
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 treatment1600 mgdie per 60 days Cebrolux Tubilux Italy
Methods In T-OAG NT-OAG and T-NION patients Visual Evoked Potentials VEPswere 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 85356727 | OTHER | FGBBIETTI | None |