- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01091896
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage
March 23, 2010 updated by: University of Sao Paulo
Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy.
Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy.
We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery
Study Type
Interventional
Enrollment (Anticipated)
1
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hospital das Clínicas de Ribeirão Preto - USP
Study Locations
-
-
SP
-
Ribeirão Preto, SP, Brazil, 14049-990
- Recruiting
- Hospital das Clínicas de Ribeirão Preto - University of São Paulo
-
Contact:
- Felipe Almeida, MD
- Phone Number: 2523 16 3602-2523
- Email: felipeppalmeida@yahoo.com.br
-
Principal Investigator:
- Felipe Almeida, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: 1 - no bevacizumab
Patients will not receive bevacizumab before nor during vitrectomy
|
|
EXPERIMENTAL: 2- bevacizumab before vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
|
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
|
EXPERIMENTAL: 3- bevacizumab after vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
|
1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrent vitreous hemorrhage incidence after vitrectomy
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual outcome
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Felipe Almeida, MD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (ANTICIPATED)
September 1, 2010
Study Completion (ANTICIPATED)
March 1, 2011
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 23, 2010
First Posted (ESTIMATE)
March 24, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
March 24, 2010
Last Update Submitted That Met QC Criteria
March 23, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Eye Diseases
- Neoplastic Processes
- Eye Hemorrhage
- Neoplasm Metastasis
- Hemorrhage
- Vitreous Hemorrhage
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- IBEViH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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