Clinical trial NCT01854593: Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Official title: Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Proliferative Diabetic Retinopathy
Diabetic Traction Retinal Detachment
Vitreous Hemorrhage
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 69
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reoperation
timeFrame: 1 month
Secondary outcomes:
measure: Intra Operative Hemorrhage
timeFrame: End of the surgery.
measure: Postoperative Vitreous Hemorrhage.
timeFrame: 1 month
measure: Vascular Endothelial Growth Factor Concentration in Vitreous
timeFrame: Start of surgery.
measure: Endolaser Photocoagulation
timeFrame: End of surgery.
measure: Iatrogenic Retinal Tears
timeFrame: End of surgery.
measure: Surgical Time
timeFrame: End of surgery.
measure: Postoperative Best Corrected Visual Acuity
timeFrame: 1 mouth after surgery.
measure: Best Corrected Visual Acuity Change
timeFrame: 1 month
measure: Postoperative Neovascular Glaucoma
timeFrame: Within 1 month after the surgery.
measure: Elevated Intraocular Pressure
timeFrame: Within 1 month after the surgery.
measure: Gas Tamponade
timeFrame: End of surgery.
measure: Silicon Oil Tamponade
timeFrame: End of surgery.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Surugadai Nihon University Hospital
Study officials:
name: Ayumu Manabe
role: STUDY_CHAIR
References: