Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
July 14, 2014
CompletedJuly 14, 2014
June 1, 2014
1.3 years
May 13, 2013
December 29, 2013
June 11, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Reoperation
Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
1 month
Secondary Outcomes (12)
Intra Operative Hemorrhage
End of the surgery.
Postoperative Vitreous Hemorrhage.
1 month
Vascular Endothelial Growth Factor Concentration in Vitreous
Start of surgery.
Endolaser Photocoagulation
End of surgery.
Iatrogenic Retinal Tears
End of surgery.
- +7 more secondary outcomes
Study Arms (2)
Bevacizumab injection and vitrectomy
ACTIVE COMPARATOR0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.
Sham injection and vitrectomy
SHAM COMPARATORSham injection one day before vitrectomy.
Interventions
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
vitrectomy of 25 gauge system.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
- Indicated for vitrectomy
You may not qualify if:
- History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nihon Universitylead
Study Sites (1)
Surugadai Nihon University Hospital
Tokyo, 101-8309, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ayumu Manabe
- Organization
- Department of Ophthalmology, Surugadai Hospital of Nihon University
Study Officials
- STUDY CHAIR
Ayumu Manabe
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ayumu Manabe
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 15, 2013
Study Start
May 1, 2012
Primary Completion
August 1, 2013
Study Completion
March 1, 2014
Last Updated
July 14, 2014
Results First Posted
July 14, 2014
Record last verified: 2014-06