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

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ClinicalTrials.gov Identifier: NCT01854593
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Ayumu Manabe, Nihon University

Study Description
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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
Proliferative Diabetic Retinopathy Diabetic Traction Retinal Detachment Vitreous Hemorrhage Drug: Bevacizumab Procedure: Vitrectomy Device: Sham injection 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
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Study Type : Interventional  (Clinical Trial)
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 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Reoperation [ Time Frame: 1 month ]
    Vitreoretinal reoperation due to recurrent vitreous hemorrhage.


Secondary Outcome Measures :
  1. Intra Operative Hemorrhage [ Time Frame: End of the surgery. ]
    Calculate the number of coagulators for the intra operative hemorrhage.

  2. Postoperative Vitreous Hemorrhage. [ Time Frame: 1 month ]
    Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.

  3. Vascular Endothelial Growth Factor Concentration in Vitreous [ Time Frame: Start of surgery. ]
    Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.

  4. Endolaser Photocoagulation [ Time Frame: End of surgery. ]
    Number of intraoperative endolaser photocoagulation.

  5. Iatrogenic Retinal Tears [ Time Frame: End of surgery. ]
    The number of participants who had intraoperative iatrogenic retinal tears.

  6. Surgical Time [ Time Frame: End of surgery. ]
  7. Postoperative Best Corrected Visual Acuity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within 1 month after the surgery. ]
    The number of participants with progressive or persistent neovascular glaucoma after surgery.

  10. Elevated Intraocular Pressure [ Time Frame: Within 1 month after the surgery. ]
    The number of participants with elevated intraocular pressure after surgery.

  11. Gas Tamponade [ Time Frame: End of surgery. ]
    The number of participants with gas tamponade at the end of the surgery.

  12. Silicon Oil Tamponade [ Time Frame: End of surgery. ]
    The number of participants with silicon oil tamponade at the end of the surgery.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854593


Locations
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Japan
Surugadai Nihon University Hospital
Tokyo, Japan, 101-8309
Sponsors and Collaborators
Nihon University
Investigators
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Study Chair: Ayumu Manabe
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ayumu Manabe, Nihon University
ClinicalTrials.gov Identifier: NCT01854593    
Other Study ID Numbers: CCT-NAPN-23170
First Posted: May 15, 2013    Key Record Dates
Results First Posted: July 14, 2014
Last Update Posted: July 14, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
Vitreous Hemorrhage
Hemorrhage
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors