N/A
N=126
Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy
Proliferative Diabetic Retinopathy · Vitreous Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00745498 ↗Enrolled (actual)
126
Serious AEs
0.8%
Results posted
Dec 2015
Primary outcome: Primary: Recurrent VH Incidence (Early and Late) — 22.2; 10.8; 32.4; 11.1 Percentage of participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bevacizumab (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Bundang Hospital
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrent VH Incidence (Early and Late) |
22.2; 10.8; 32.4; 11.1; 16.2; 14.7 | <0.05 sig |
| SECONDARY Initial Time of Vitreous Clearing (ITVC) |
26.4; 10.3; 25.2 | — |
| SECONDARY Visual Outcome |
0.62; 0.68; 0.51 | — |
| SECONDARY Postoperative Resolution of Neovascularization |
— | — |
Summary
The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment)
Exclusion Criteria
- Follow-up period of less than 6 months
- Intraoperative use of long-acting gas or silicone oil
- Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage
- Not first vitrectomy
- Uncontrolled hypertension
- Medical history of abnormal blood coagulation
- Time interval between IVB injection and PPV longer than 2 weeks and recent history (within 3 months) of IVB treatment
Data sourced from ClinicalTrials.gov (NCT00745498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.