search
Back to results

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

Primary Purpose

Glaucoma, Optic Neuropathy, Ischemic, Visual Pathway Disorder

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Citicoline
Sponsored by
Fondazione G.B. Bietti, IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Optic Neuropathy, Ischemic, Visual Pathways,, Optic nerve, Neural conduction

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Fondazione G.B. Bietti- IRCCS
  • Fondazione G.B. Bietti-IRCCS

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Citicoline treatment

Arm Description

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)

Outcomes

Primary Outcome Measures

VEPs responses
P100 Implicit time and N75-P100 Amplitude

Secondary Outcome Measures

Visual Field Defects
Humphrey 24/1: Mean Deviation and Corrected Pattern Standard Deviation

Full Information

First Posted
November 28, 2006
Last Updated
February 1, 2021
Sponsor
Fondazione G.B. Bietti, IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT00404729
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 28, 2005 (Actual)
Primary Completion Date
February 28, 2006 (Actual)
Study Completion Date
July 30, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione G.B. Bietti, IRCCS

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Optic Neuropathy, Ischemic, Visual Pathway Disorder, Optic Nerve, Neural Conduction
Keywords
Glaucoma, Optic Neuropathy, Ischemic, Visual Pathways,, Optic nerve, Neural conduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citicoline treatment
Arm Type
Other
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Citicoline
Intervention Description
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)
Primary Outcome Measure Information:
Title
VEPs responses
Description
P100 Implicit time and N75-P100 Amplitude
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Visual Field Defects
Description
Humphrey 24/1: Mean Deviation and Corrected Pattern Standard Deviation
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Parisi, MD
Organizational Affiliation
Fondazione G.B. Bietti-IRCCS, Rome, Italy
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione G.B. Bietti- IRCCS
City
Rome
ZIP/Postal Code
00199
Country
Italy
Facility Name
Fondazione G.B. Bietti-IRCCS
City
Rome
ZIP/Postal Code
00199
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
16249960
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.
Results Reference
result
Links:
URL
http://www.fondazionebietti.it
Description
Fondazione G.B. Bietti-IRCCS activity (in italian language)

Learn more about this trial

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

We'll reach out to this number within 24 hrs