Clinical Trials Logo
  1. Home
  2. Hemorrhage
  3. NCT01151722
  4. Details
NCT01151722 Clinical Trial

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Hemorrhage Clinical Trial

— ABeVi  

Official title:
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01151722
Other study ID # HCRP22
Secondary ID
Status Recruiting
Phase Phase 2
First received June 25, 2010
Last updated June 25, 2010
Start date December 2009

Study information
Verified date February 2010
Source University of Sao Paulo
Contact Felipe Almeida
Email felipeppalmeida@yahoo.com.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.

Recruitment information / eligibility
Status Recruiting
Enrollment 2
Est. completion date
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

- follow-up period of less than 3 months

- not first vitrectomy

- abnormal blood coagulation

- uncontrolled hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• bevacizumab injection
bevacizumab injection before vitrectomy
• bevacizumab injection
bevacizumab injection after vitrectomy

Locations
Country Name City State
Brazil Hospital das Clínicas de Ribeirão Preto - University of São Paulo Ribeirão Preto Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitreous hemorrhage recurrence 3 months No
See also
  Status Clinical Trial Phase
Completed NCT02815670 - Reversal Dabigatran Anticoagulant Effect With Idarucizumab Phase 3
Completed NCT04588350 - Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery N/A
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02569606 - Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Completed NCT02554006 - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings N/A
Recruiting NCT02446730 - Efficacy and Safety of BiomatrixTM Stent and 5mg-Maintenance Dose of Prasugrel in Patients With Acute Coronary Syndrome Phase 4
Completed NCT01955720 - Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran Phase 1
Completed NCT01935427 - Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume N/A
Recruiting NCT01709786 - Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage N/A
Completed NCT01191554 - Dose-ranging Study of Tranexamic Acid in Valve Surgery N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Completed NCT01136590 - Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery Phase 4
Completed NCT01085006 - The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery Phase 1/Phase 2
Completed NCT00700141 - Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil® N/A
Completed NCT00375466 - Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery. N/A
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00147420 - RCT of Zhi Byed 11 (ZB11) Versus Misoprostol in Tibet N/A
Recruiting NCT05945680 - Tranexamic Acid in Breast Esthetic Surgery. Phase 4
Completed NCT03273322 - Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure Phase 2/Phase 3
Withdrawn NCT05672407 - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery Phase 4