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

NCT00404729 | Completed Phase 4

• 2 other identifiers: 8621688085356727
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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)

Conditions

Glaucoma; Optic Neuropathy, Ischemic; Visual Pathway Disorder; Optic Nerve; Neural Conduction

Keywords

Glaucoma; Optic Neuropathy, Ischemic; Visual Pathways,; Optic nerve; Neural conduction

Outcome Measures

Primary Outcomes (1)

• VEPs responses

  P100 Implicit time and N75-P100 Amplitude

  24 months

Secondary Outcomes (1)

• Visual Field Defects

  24 months

Study Arms (1)

Citicoline treatment

OTHER

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)

Drug: Citicoline

Interventions

Citicoline DRUG

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)

Citicoline treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (2)

Fondazione G.B. Bietti- IRCCS

Rome, 00199, Italy

Location

Fondazione G.B. Bietti-IRCCS

Rome, 00199, Italy

Location

Related Publications (1)

• 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.

  PMID: 16249960 RESULT

Related Links

• Fondazione G.B. Bietti-IRCCS activity (in italian language)

MeSH Terms

Conditions

Glaucoma; Optic Neuropathy, Ischemic

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Vincenzo Parisi, MD

  Fondazione G.B. Bietti-IRCCS, Rome, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: February 28, 2005
• Primary Completion: February 28, 2006
• Study Completion: July 30, 2006
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

IT (2)