Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).
Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
-
Tokyo, Japão, 101-8309
- Surugadai Nihon university hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
Exclusion Criteria:
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
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 |
|---|---|
|
Comparador Ativo: Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
|
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Outros nomes:
vitrectomy of 25 gauge system.
|
|
Comparador Falso: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
|
vitrectomy of 25 gauge system.
Sham injection one day before vitrectomy
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Reoperation
Prazo: 1 month
|
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
|
1 month
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intra Operative Hemorrhage
Prazo: End of the surgery.
|
Calculate the number of coagulators for the intra operative hemorrhage.
|
End of the surgery.
|
|
Postoperative Vitreous Hemorrhage.
Prazo: 1 month
|
Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
|
1 month
|
|
Vascular Endothelial Growth Factor Concentration in Vitreous
Prazo: Start of surgery.
|
Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
|
Start of surgery.
|
|
Endolaser Photocoagulation
Prazo: End of surgery.
|
Number of intraoperative endolaser photocoagulation.
|
End of surgery.
|
|
Iatrogenic Retinal Tears
Prazo: End of surgery.
|
The number of participants who had intraoperative iatrogenic retinal tears.
|
End of surgery.
|
|
Surgical Time
Prazo: End of surgery.
|
End of surgery.
|
|
|
Postoperative Best Corrected Visual Acuity
Prazo: 1 mouth after surgery.
|
Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome. |
1 mouth after surgery.
|
|
Best Corrected Visual Acuity Change
Prazo: 1 month
|
Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome. |
1 month
|
|
Postoperative Neovascular Glaucoma
Prazo: Within 1 month after the surgery.
|
The number of participants with progressive or persistent neovascular glaucoma after surgery.
|
Within 1 month after the surgery.
|
|
Elevated Intraocular Pressure
Prazo: Within 1 month after the surgery.
|
The number of participants with elevated intraocular pressure after surgery.
|
Within 1 month after the surgery.
|
|
Gas Tamponade
Prazo: End of surgery.
|
The number of participants with gas tamponade at the end of the surgery.
|
End of surgery.
|
|
Silicon Oil Tamponade
Prazo: End of surgery.
|
The number of participants with silicon oil tamponade at the end of the surgery.
|
End of surgery.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Ayumu Manabe
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças cardiovasculares
- Doenças Vasculares
- Doenças oculares
- Doenças do Sistema Endócrino
- Angiopatias Diabéticas
- Complicações do Diabetes
- Diabetes Mellitus
- Hemorragia Ocular
- Doenças Retinianas
- Retinopatia diabética
- Hemorragia
- Descolamento da retina
- Hemorragia Vítrea
- Efeitos Fisiológicos das Drogas
- Agentes Antineoplásicos
- Agentes Antineoplásicos Imunológicos
- Inibidores de angiogênese
- Agentes Moduladores da Angiogênese
- Substâncias de crescimento
- Inibidores de crescimento
- Bevacizumabe
Outros números de identificação do estudo
- CCT-NAPN-23170
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 .