Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.
Proliferative Diabetic Retinopathy
Diabetic Traction Retinal Detachment
Device: Sham injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy|
- Reoperation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
- Intra Operative Hemorrhage [ Time Frame: End of the surgery. ] [ Designated as safety issue: Yes ]Calculate the number of coagulators for the intra operative hemorrhage.
- Postoperative Vitreous Hemorrhage. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
- Vascular Endothelial Growth Factor Concentration in Vitreous [ Time Frame: Start of surgery. ] [ Designated as safety issue: Yes ]Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
- Endolaser Photocoagulation [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]Number of intraoperative endolaser photocoagulation.
- Iatrogenic Retinal Tears [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]The number of participants who had intraoperative iatrogenic retinal tears.
- Surgical Time [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]
- Postoperative Best Corrected Visual Acuity [ Time Frame: 1 mouth after surgery. ] [ Designated as safety issue: Yes ]
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.
- Best Corrected Visual Acuity Change [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.
The higher values represent a worse outcome.
- Postoperative Neovascular Glaucoma [ Time Frame: Within 1 month after the surgery. ] [ Designated as safety issue: Yes ]The number of participants with progressive or persistent neovascular glaucoma after surgery.
- Elevated Intraocular Pressure [ Time Frame: Within 1 month after the surgery. ] [ Designated as safety issue: No ]The number of participants with elevated intraocular pressure after surgery.
- Gas Tamponade [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]The number of participants with gas tamponade at the end of the surgery.
- Silicon Oil Tamponade [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]The number of participants with silicon oil tamponade at the end of the surgery.
|Study Start Date:||May 2012|
|Study Completion Date:||March 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 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)
Other Name: AvastinProcedure: Vitrectomy
vitrectomy of 25 gauge system.
Sham Comparator: Sham injection and vitrectomy
Sham injection one day before vitrectomy.
vitrectomy of 25 gauge system.Device: Sham injection
Sham injection one day before vitrectomy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01854593
|Surugadai Nihon University Hospital|
|Tokyo, Japan, 101-8309|
|Study Chair:||Ayumu Manabe|