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The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.
Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and 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 intravitreal bevacizumab (IVB) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.
To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative IVB injection on postoperative vitreous hemorrhage after diabetic vitrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preop IVB | Experimental | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy |
|
| Intraop IVB | Experimental | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
|
| No IVB | No Intervention | Patients will not receive bevacizumab before nor during vitrectomy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent VH Incidence (Early and Late) | Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring <= 4 weeks and "late recurrent VH" was VH occurring >4 weeks after surgery. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Time of Vitreous Clearing (ITVC) | The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Hyung Park, M.D. | Seoul National Univeristy Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Gyunggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16829817 | Background | Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available. |
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If indications for PPV included proliferative diabetic retinopathy (PDR) related complications such as nonclearing vitreous hemorrhage (VH), macula-involving or -threatening tractional retinal detachment (TRD) or fibrovascular proliferation with vitreoretinal adhesions, the patient was enrolled in the study.
Consecutive diabetic patients requiring pars plana vitrectomy (PPV) for complications of diabetic retinopathy at Seoul National University Bundang Hospital were referred to assess eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preop IVB | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy |
| FG001 | Introp IVB | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
| FG002 | No IVB | Patients will not receive bevacizumab before nor during vitrectomy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preop IVB | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy |
| BG001 | Intraop IVB | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent VH Incidence (Early and Late) | Recurrent VH was defined as a new episode of grade 1 or more VH occurring more than 1 week after surgery. "Early recurrent VH" was VH occurring <= 4 weeks and "late recurrent VH" was VH occurring >4 weeks after surgery. | With study power of 80%, significance level of 0.05, assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated. The ITT approach was used for analysis. | Posted | Number | Percentage of participants | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preop IVB | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous retinal detachment immediately following operation | Eye disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neovascular glaucoma following surgery | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Se Joon Woo | Seoul National University Bundang Hospital Department of Ophthalmology | +82-31-787-7377 | sejoon1@hanmail.net |
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| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Visual Outcome |
Best-corrected visual acuity (BCVA) at postoperative 6 months |
| 6 months |
| Postoperative Resolution of Neovascularization | 6 months |
| Non-PDR related VH |
|
| Edophthalmitis after preoperative IVB |
|
| BG002 | No IVB | Patients will not receive bevacizumab before nor during vitrectomy |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy |
| OG002 | No IVB | Patients will not receive bevacizumab before nor during vitrectomy |
|
|
|
| Secondary | Initial Time of Vitreous Clearing (ITVC) | The interval in number of days for VH of grade 1 or more observed at postoperative day 1 to clear-up completely. VH of grade 1 was defined as mild vitreous hemorrhage with visible fundus details, but difficult to evaluate the retinal nerve fiber layer or small vessels. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| Secondary | Visual Outcome | Best-corrected visual acuity (BCVA) at postoperative 6 months | Posted | Mean | Standard Deviation | logMAR | 6 months |
|
|
|
| Secondary | Postoperative Resolution of Neovascularization | Not Posted | 6 months |
| 0 |
| 41 |
| 1 |
| 41 |
| EG001 | Intraop IVB | Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy | 0 | 43 | 3 | 43 |
| EG002 | No IVB | Patients will not receive bevacizumab before nor during vitrectomy | 1 | 42 | 1 | 42 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |