- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Lombardy
-
Pavia, Lombardy, Italien, 27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Placebo-Komparator: 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)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the mean deviation (MD) index
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Change in the implicit P100 latency measured via PEV (visual evoked potentials)
Zeitfenster: 24 months after surgery
|
24 months after surgery
|
|
Change in p50 amplitude measured using PERG (retinal evoked potentials)
Zeitfenster: 24 months after surgery
|
24 months after surgery
|
|
Incidence of progression as determined by the Glaucoma Progression Analysis (GPA) programme
Zeitfenster: 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)
Zeitfenster: 24 months after surgery
|
24 months after surgery
|
|
Change in choroidal hypoperfusion areas (dropouts) measured using A-OCT (Optical coherence tomography)
Zeitfenster: 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)
Zeitfenster: 24 months after surgery
|
24 months after surgery
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CHIRCIT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Glaucoma Therapy
-
National University Hospital, SingaporeAbgeschlossenChronisches Engwinkelglaukom | Primärer Winkelverschluss | Primärer Angle Closure-Verdächtiger | Fellow Eyes of Acute Angle Closure GlaucomaSingapur
-
Sigmund Freud PrivatUniversitatNoch keine RekrutierungStreicheln | Akuter ischämischer Schlaganfall | Thrombolyse | DAPT (Duale Thrombozytenaggregationshemmer-Therapie) | SAPT (Single Antiplatelet Therapy)Österreich, Deutschland, Schweiz
-
Baylor College of MedicinePatient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; The... und andere MitarbeiterAbgeschlossenHerzinsuffizienz im Endstadium | Bridge-to-Transplant-LVAD-Platzierung (BTT) | Destination Therapy LVAD-Platzierung (DT) | Ablehnung der LVAD-Platzierung (Ablehner) | LVAD-BetreuerVereinigte Staaten
-
OCEAN-SHD Study GroupRekrutierungAortenstenose | Aspirin | TAVI (Transkatheter-Aortenklappenimplantation) | DAPT (Duale Thrombozytenaggregationshemmer-Therapie) | SAPT (Single Antiplatelet Therapy)Japan
-
Dana-Farber Cancer InstituteAbgeschlossenBrustkrebs | Magen-Darm-Krebs | Oral Cancer Directed Therapy | Orale ChemotherapieVereinigte Staaten
Klinische Studien zur Citicoline
-
Mclean HospitalZurückgezogenSchädel-Hirn-TraumaVereinigte Staaten
-
Deborah Yurgelun-ToddAbgeschlossenNeurokognitive VerbesserungVereinigte Staaten
-
Deborah Yurgelun-ToddZurückgezogenSchädel-Hirn-Trauma | Drogenmissbrauch | Drogenabhängigkeit
-
Armed Forces Hospital, PakistanUnbekanntHypoxisch-ischämische EnzephalopathiePakistan
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)AbgeschlossenMarihuana-MissbrauchVereinigte Staaten
-
Fondazione G.B. Bietti, IRCCSAbgeschlossenGlaukom | Optikusneuropathie, Ischämisch | Sehnerv | Sehstörung | NeuralleitungItalien
-
Ain Shams UniversityKafrelsheikh UniversityRekrutierung
-
Istituto di Ricerca Neuroftalmologia S.r.l.Fondazione G.B. Bietti, IRCCSAbgeschlossen
-
University of Texas Southwestern Medical CenterZurückgezogen
-
Armed Forces Hospital, PakistanRekrutierungRolle von Citicolin bei der Behandlung von Neugeborenen mit hypoxischer ischämischer EnzephalopathieHypoxische ischämische Enzephalopathie des NeugeborenenPakistan