- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Lombardy
-
Pavia, Lombardy, Itália, 27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
|
Comparador de 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)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in the mean deviation (MD) index
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Change in the implicit P100 latency measured via PEV (visual evoked potentials)
Prazo: 24 months after surgery
|
24 months after surgery
|
|
Change in p50 amplitude measured using PERG (retinal evoked potentials)
Prazo: 24 months after surgery
|
24 months after surgery
|
|
Incidence of progression as determined by the Glaucoma Progression Analysis (GPA) programme
Prazo: 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)
Prazo: 24 months after surgery
|
24 months after surgery
|
|
Change in choroidal hypoperfusion areas (dropouts) measured using A-OCT (Optical coherence tomography)
Prazo: 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)
Prazo: 24 months after surgery
|
24 months after surgery
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- CHIRCIT
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .