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Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

Sponsor
Nihon University (Other)
Overall Status
Completed
CT.gov ID
NCT01854593
Collaborator
(none)
69
Enrollment
1
Location
2
Arms
22
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).

Between June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bevacizumab injection and vitrectomy

0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.

Drug: Bevacizumab
0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
Other Names:
  • Avastin

    • Procedure: Vitrectomy
    vitrectomy of 25 gauge system.
    Sham Comparator: Sham injection and vitrectomy

    Sham injection one day before vitrectomy.

    Procedure: Vitrectomy
    vitrectomy of 25 gauge system.

    Device: Sham injection
    Sham injection one day before vitrectomy

    Outcome Measures

    Primary Outcome Measures

    1. Reoperation [1 month]

      Vitreoretinal reoperation due to recurrent vitreous hemorrhage.

    Secondary Outcome Measures

    1. Intra Operative Hemorrhage [End of the surgery.]

      Calculate the number of coagulators for the intra operative hemorrhage.

    2. Postoperative Vitreous Hemorrhage. [1 month]

      Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.

    3. Vascular Endothelial Growth Factor Concentration in Vitreous [Start of surgery.]

      Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.

    4. Endolaser Photocoagulation [End of surgery.]

      Number of intraoperative endolaser photocoagulation.

    5. Iatrogenic Retinal Tears [End of surgery.]

      The number of participants who had intraoperative iatrogenic retinal tears.

    6. Surgical Time [End of surgery.]

    7. Postoperative Best Corrected Visual Acuity [1 mouth after surgery.]

      Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.

    8. Best Corrected Visual Acuity Change [1 month]

      Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome.

    9. Postoperative Neovascular Glaucoma [Within 1 month after the surgery.]

      The number of participants with progressive or persistent neovascular glaucoma after surgery.

    10. Elevated Intraocular Pressure [Within 1 month after the surgery.]

      The number of participants with elevated intraocular pressure after surgery.

    11. Gas Tamponade [End of surgery.]

      The number of participants with gas tamponade at the end of the surgery.

    12. Silicon Oil Tamponade [End of surgery.]

      The number of participants with silicon oil tamponade at the end of the surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)

    • Indicated for vitrectomy

    Exclusion Criteria:
    • History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surugadai Nihon University Hospital Tokyo Japan 101-8309

    Sponsors and Collaborators

    • Nihon University

    Investigators

    • Study Chair: Ayumu Manabe,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayumu Manabe, Ayumu Manabe, Nihon University
    ClinicalTrials.gov Identifier:
    NCT01854593
    Other Study ID Numbers:
    • CCT-NAPN-23170
    First Posted:
    May 15, 2013
    Last Update Posted:
    Jul 14, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Retinal Detachment
    Vitreous Hemorrhage
    Hemorrhage
    Bevacizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Sham injection: Sham injection one day before vitrectomy Vitrectomy: vitrectomy of 25 gauge system.
    Period Title: Overall Study
    STARTED 34 35
    COMPLETED 32 34
    NOT COMPLETED 2 1

    Baseline Characteristics

    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy Total
    Arm/Group Description 0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Sham injection: Sham injection one day before vitrectomy Vitrectomy: vitrectomy of 25 gauge system. Total of all reporting groups
    Overall Participants 32 34 66
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    59.9
    (11.8)
    59.2
    (12.9)
    59.6
    (12.4)
    Sex: Female, Male (Count of Participants)
    Female
    10
    31.3%
    2
    5.9%
    12
    18.2%
    Male
    22
    68.8%
    32
    94.1%
    54
    81.8%
    Preoperative best corrected visual acuity (LogMAR) [Log Mean (Standard Deviation) ]
    Log Mean (Standard Deviation) [LogMAR]
    1.09
    (0.60)
    1.14
    (0.58)
    1.11
    (0.59)
    Intra Ocular Pressure (mm Hg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mm Hg]
    15.3
    (2.69)
    14.6
    (3.42)
    15.0
    (3.11)
    Hypertension (participants) [Number]
    Yes
    14
    43.8%
    16
    47.1%
    30
    45.5%
    No
    18
    56.3%
    18
    52.9%
    36
    54.5%
    Hyperlipidemia (participants) [Number]
    Yes
    5
    15.6%
    7
    20.6%
    12
    18.2%
    No
    27
    84.4%
    27
    79.4%
    54
    81.8%
    HbA1c (%) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [%]
    8.0
    (1.7)
    7.6
    (2.0)
    7.8
    (1.6)
    Use of anticoagulants (participants) [Number]
    Yes
    7
    21.9%
    8
    23.5%
    15
    22.7%
    No
    25
    78.1%
    26
    76.5%
    51
    77.3%
    Lens status (participants) [Number]
    phakic
    28
    87.5%
    31
    91.2%
    59
    89.4%
    pseudophakic
    4
    12.5%
    3
    8.8%
    7
    10.6%
    Persistent vitreous hemorrhage (participants) [Number]
    Number [participants]
    29
    90.6%
    30
    88.2%
    59
    89.4%
    Previous panretinal photocoagulation (participants) [Number]
    None
    9
    28.1%
    11
    32.4%
    20
    30.3%
    Incomplete
    23
    71.9%
    23
    67.6%
    46
    69.7%
    preoperative Iris neovascularization or neovascular glaucoma (participants) [Number]
    Number [participants]
    2
    6.3%
    2
    5.9%
    4
    6.1%

    Outcome Measures

    1. Secondary Outcome
    Title Intra Operative Hemorrhage
    Description Calculate the number of coagulators for the intra operative hemorrhage.
    Time Frame End of the surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Mean (Standard Deviation) [coagulators]
    0.63
    (1.0)
    1.3
    (1.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.025
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Secondary Outcome
    Title Postoperative Vitreous Hemorrhage.
    Description Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    3
    9.4%
    13
    38.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method Chi-squared
    Comments
    3. Primary Outcome
    Title Reoperation
    Description Vitreoretinal reoperation due to recurrent vitreous hemorrhage.
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    1
    3.1%
    7
    20.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.033
    Comments
    Method Fisher Exact
    Comments
    4. Secondary Outcome
    Title Vascular Endothelial Growth Factor Concentration in Vitreous
    Description Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.
    Time Frame Start of surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Mean (Standard Deviation) [μg/ml]
    25.0
    (13.6)
    1315
    (1153)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    5. Secondary Outcome
    Title Endolaser Photocoagulation
    Description Number of intraoperative endolaser photocoagulation.
    Time Frame End of surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Mean (Standard Deviation) [photocoagulation]
    1260
    (686)
    1335
    (663)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.667
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    6. Secondary Outcome
    Title Iatrogenic Retinal Tears
    Description The number of participants who had intraoperative iatrogenic retinal tears.
    Time Frame End of surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    5
    15.6%
    5
    14.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.593
    Comments
    Method Fisher Exact
    Comments
    7. Secondary Outcome
    Title Surgical Time
    Description
    Time Frame End of surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Mean (Standard Deviation) [minutes]
    49
    (20)
    56
    (27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.298
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    8. Secondary Outcome
    Title Postoperative Best Corrected Visual Acuity
    Description Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis. The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.
    Time Frame 1 mouth after surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Mean (Standard Deviation) [LogMAR]
    0.46
    (0.54)
    0.43
    (0.48)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.929
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    9. Secondary Outcome
    Title Best Corrected Visual Acuity Change
    Description Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity. The higher values represent a worse outcome.
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Mean (Standard Deviation) [LogMAR]
    -0.63
    (0.61)
    -0.73
    (0.80)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.445
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    10. Secondary Outcome
    Title Postoperative Neovascular Glaucoma
    Description The number of participants with progressive or persistent neovascular glaucoma after surgery.
    Time Frame Within 1 month after the surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab Injection and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    0
    0%
    3
    8.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.131
    Comments
    Method Chi-squared
    Comments
    11. Secondary Outcome
    Title Elevated Intraocular Pressure
    Description The number of participants with elevated intraocular pressure after surgery.
    Time Frame Within 1 month after the surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab Injection and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    2
    6.3%
    6
    17.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.149
    Comments
    Method Fisher Exact
    Comments
    12. Secondary Outcome
    Title Gas Tamponade
    Description The number of participants with gas tamponade at the end of the surgery.
    Time Frame End of surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab Injection and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    23
    71.9%
    24
    70.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.670
    Comments
    Method Fisher Exact
    Comments
    13. Secondary Outcome
    Title Silicon Oil Tamponade
    Description The number of participants with silicon oil tamponade at the end of the surgery.
    Time Frame End of surgery.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bevacizumab Injection and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    Measure Participants 32 34
    Number [participants]
    4
    12.5%
    6
    17.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bevacizumab and Vitrectomy, Sham Injection and Vitrectomy
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.378
    Comments
    Method Chi-squared
    Comments

    Adverse Events

    Time Frame 1 month
    Adverse Event Reporting Description 1 month after vitrectomy.
    Arm/Group Title Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Arm/Group Description 0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy. Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation) Vitrectomy: vitrectomy of 25 gauge system. Sham injection one day before operation and vitrectomy. Vitrectomy: vitrectomy of 25 gauge system. Sham injection: Sham injection one day before vitrectomy
    All Cause Mortality
    Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/32 (0%) 0/34 (0%)
    Other (Not Including Serious) Adverse Events
    Bevacizumab and Vitrectomy Sham Injection and Vitrectomy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/32 (0%) 0/34 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Ayumu Manabe
    Organization Department of Ophthalmology, Surugadai Hospital of Nihon University
    Phone +81-3-3293-1711 ext 429
    Email ayumu.m76@gmail.com
    Responsible Party:
    Ayumu Manabe, Ayumu Manabe, Nihon University
    ClinicalTrials.gov Identifier:
    NCT01854593
    Other Study ID Numbers:
    • CCT-NAPN-23170
    First Posted:
    May 15, 2013
    Last Update Posted:
    Jul 14, 2014
    Last Verified:
    Jun 1, 2014