- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07567651
Citicoline and Filtration Surgery
A Single-centre, Randomised, Double-blind Study to Assess the Efficacy of Citicoline Compared With Placebo on Visual Function in Glaucoma Patients Undergoing Subconjunctival Filtering Surgery for Glaucoma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Lombardy
-
Pavia, Lombardy, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- age > 18 years
- Ability to understand the protocol and provide informed consent to participate in the study
- Diagnosis of primary or secondary open-angle glaucoma (PEX - PIG) and the need to undergo subconjunctival filtration surgery due to signs of morphological/functional progression of the condition or failure to achieve target pressure with medical or pre-surgical therapy.
The diagnosis of glaucoma is defined by the presence of typical ophthalmoscopic damage to the optic nerve head and the consequent visual field defect. In particular, a glaucomatous visual field defect will be considered as such if there is a cluster of 3 or more contiguous points in the pattern deviation plot with a probability of occurrence in the normal population of less than 5%, one of which has a probability of less than 1%, a pattern standard deviation with a probability of less than 5%, or a GHT result outside the normal limits.
- Early to moderate visual field defect, according to the Hodapp-Parrish-Anderson classification, i.e. with MD up to -12 dB, as determined by the Humphrey 24-2 SITA Standard computerised test.
- Rate of visual field defect progression > 0.5 dB/year, in the 2 years prior to surgery.
- At least 3 visual field examinations performed using standard perimetry in the 2 years prior to surgery.
Exclusion Criteria:
- Diagnosis of angle-closure glaucoma
- Previous glaucoma surgery (trabeculectomy, valve implantation or placement of other devices, cyclophotocoagulation)
- Previous vitreoretinal or corneal eye surgery
- Visual, neurological or general medical conditions that may affect the visual field, electrophysiological tests, OCT or A-OCT scans
- Systemic administration (oral or parenteral) of cerebral vasoactive drugs, neurotrophic agents, lutein, zeaxanthin, docosahexaenoic acid, ubiquinone and/or its derivatives, citicoline and/or its derivatives within 6 months prior to enrolment in the study
- Topical therapy with citicoline and/or its derivatives within 6 months prior to enrolment in the study
- Known or suspected allergy or sensitisation to the study product
- Pregnancy or breastfeeding
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: citicolina
The experimental group will be treated with citicoline in oral solution (Neurotidine, Omikron, Italy) at a dose of 10 ml per day, starting two weeks before surgery and continuing for the following 24 months.
|
Citicoline is a mononucleotide composed of ribose, pyrophosphate, cytosine and choline. It is the natural intracellular precursor of phosphatidylcholine. As an intermediate in the synthesis of phosphatidylcholine, citicoline acts at a structural level, promoting the synthesis of membrane phospholipids and inhibiting their degradation. In addition to its structural action, it has a functional effect (as a neuroenhancer) in that it increases the synthesis of neurotransmitters such as noradrenaline, acetylcholine, serotonin and dopamine, which are involved in visual signal transmission at both the retinal and post-retinal levels. In addition to its structural effects, it also has a functional effect (as a neuroenhancer) in that it increases the synthesis of neurotransmitters such as noradrenaline, acetylcholine, serotonin and dopamine, which are involved in the transmission of visual signals at both the retinal and post-retinal levels. |
|
Comparatore placebo: Placebo
The placebo arm will receive a solution consisting of the Neurotidine vehicle (placebo) according to the same dosing regimen and schedule.
|
solution consisting of the Neurotidine vehicle (placebo)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in the mean deviation (MD) index
Lasso di tempo: 24 months after the operation
|
The Mean Deviation (MD) perimetric index is a measure of the average differential light sensitivity of the visual field.
It is calculated as the sum of the defects found in the individual tested loci divided by the number of such loci.
A higher MD indicates greater damage to the visual field.
The MD index is used in conjunction with other perimetric indices to assess light sensitivity and the progression of glaucomatous damage
|
24 months after the operation
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in the implicit P100 latency measured via PEV (visual evoked potentials)
Lasso di tempo: 24 months after surgery
|
24 months after surgery
|
|
Change in p50 amplitude measured using PERG (retinal evoked potentials)
Lasso di tempo: 24 months after surgery
|
24 months after surgery
|
|
Incidence of progression as determined by the Glaucoma Progression Analysis (GPA) programme
Lasso di tempo: 24 months after surgery
|
24 months after surgery
|
|
Changes in the thickness of the retinal nerve fibre layer (RNFL) and ganglion cell layer (GCC) as measured by SD-OCT (Spectral Domain Optical Coherence Tomography)
Lasso di tempo: 24 months after surgery
|
24 months after surgery
|
|
Change in choroidal hypoperfusion areas (dropouts) measured using A-OCT (Optical coherence tomography)
Lasso di tempo: 24 months after surgery
|
24 months after surgery
|
|
Changes in the total score and sub-item scores on the NEI-VFQ-25 questionnaire (National Eye Institute Visual Function Questionnaire)
Lasso di tempo: 24 months after surgery
|
24 months after surgery
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CHIRCIT
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Glaucoma Therapy
-
Tokat Gaziosmanpasa UniversityCompletatoEffetti della Pet Therapy sul sonno e sulla qualità della vitaTacchino