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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Tokyo, Japón, 101-8309
- Surugadai Nihon university hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Bevacizumab injection and vitrectomy
0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
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0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Otros nombres:
vitrectomy of 25 gauge system.
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Comparador falso: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
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vitrectomy of 25 gauge system.
Sham injection one day before vitrectomy
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reoperation
Periodo de tiempo: 1 month
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Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
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1 month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intra Operative Hemorrhage
Periodo de tiempo: End of the surgery.
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Calculate the number of coagulators for the intra operative hemorrhage.
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End of the surgery.
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Postoperative Vitreous Hemorrhage.
Periodo de tiempo: 1 month
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Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
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1 month
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Vascular Endothelial Growth Factor Concentration in Vitreous
Periodo de tiempo: Start of surgery.
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Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
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Start of surgery.
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Endolaser Photocoagulation
Periodo de tiempo: End of surgery.
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Number of intraoperative endolaser photocoagulation.
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End of surgery.
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Iatrogenic Retinal Tears
Periodo de tiempo: End of surgery.
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The number of participants who had intraoperative iatrogenic retinal tears.
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End of surgery.
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Surgical Time
Periodo de tiempo: End of surgery.
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End of surgery.
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Postoperative Best Corrected Visual Acuity
Periodo de tiempo: 1 mouth after surgery.
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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.
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Best Corrected Visual Acuity Change
Periodo de tiempo: 1 month
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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
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Postoperative Neovascular Glaucoma
Periodo de tiempo: Within 1 month after the surgery.
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The number of participants with progressive or persistent neovascular glaucoma after surgery.
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Within 1 month after the surgery.
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Elevated Intraocular Pressure
Periodo de tiempo: Within 1 month after the surgery.
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The number of participants with elevated intraocular pressure after surgery.
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Within 1 month after the surgery.
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Gas Tamponade
Periodo de tiempo: End of surgery.
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The number of participants with gas tamponade at the end of the surgery.
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End of surgery.
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Silicon Oil Tamponade
Periodo de tiempo: End of surgery.
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The number of participants with silicon oil tamponade at the end of the surgery.
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End of surgery.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Ayumu Manabe
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de los ojos
- Enfermedades del sistema endocrino
- Angiopatías diabéticas
- Complicaciones de la diabetes
- Diabetes mellitus
- Hemorragia ocular
- Enfermedades de la retina
- Retinopatía diabética
- Hemorragia
- Desprendimiento de retina
- Hemorragia Vítrea
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Bevacizumab
Otros números de identificación del estudio
- CCT-NAPN-23170
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