Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854593
• Other study ID #: CCT-NAPN-23170
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2013
• Last updated: June 11, 2014
• Start date: May 2012
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Nihon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Diabetic Traction Retinal Detachment
• Proliferative Diabetic Retinopathy
• Retinal Detachment
• Retinal Diseases
• Vitreous Hemorrhage

Intervention

Drug:
• Bevacizumab
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)

Procedure:
• Vitrectomy
vitrectomy of 25 gauge system.

Device:
• Sham injection
Sham injection one day before vitrectomy

Locations

Country	Name	City	State
Japan	Surugadai Nihon University Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nihon University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Vitreoretinal reoperation due to recurrent vitreous hemorrhage.	1 month	Yes
Secondary	Intra Operative Hemorrhage	Calculate the number of coagulators for the intra operative hemorrhage.	End of the surgery.	Yes
Secondary	Postoperative Vitreous Hemorrhage.	Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.	1 month	Yes
Secondary	Vascular Endothelial Growth Factor Concentration in Vitreous	Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.	Start of surgery.	Yes
Secondary	Endolaser Photocoagulation	Number of intraoperative endolaser photocoagulation.	End of surgery.	Yes
Secondary	Iatrogenic Retinal Tears	The number of participants who had intraoperative iatrogenic retinal tears.	End of surgery.	Yes
Secondary	Surgical Time		End of surgery.	Yes
Secondary	Postoperative Best Corrected Visual Acuity	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.	Yes
Secondary	Best Corrected Visual Acuity Change	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	Yes
Secondary	Postoperative Neovascular Glaucoma	The number of participants with progressive or persistent neovascular glaucoma after surgery.	Within 1 month after the surgery.	Yes
Secondary	Elevated Intraocular Pressure	The number of participants with elevated intraocular pressure after surgery.	Within 1 month after the surgery.	No
Secondary	Gas Tamponade	The number of participants with gas tamponade at the end of the surgery.	End of surgery.	Yes
Secondary	Silicon Oil Tamponade	The number of participants with silicon oil tamponade at the end of the surgery.	End of surgery.	Yes