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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ayumu Manabe, Nihon University
ClinicalTrials.gov Identifier:
NCT01854593
First received: May 13, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Proliferative Diabetic Retinopathy
Diabetic Traction Retinal Detachment
Vitreous Hemorrhage
Drug: Bevacizumab
Procedure: Vitrectomy
Device: Sham injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Nihon University:

Primary Outcome Measures:
  • Reoperation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Vitreoretinal reoperation due to recurrent vitreous hemorrhage.


Secondary Outcome Measures:
  • Intra Operative Hemorrhage [ Time Frame: End of the surgery. ] [ Designated as safety issue: Yes ]
    Calculate the number of coagulators for the intra operative hemorrhage.

  • Postoperative Vitreous Hemorrhage. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.

  • Vascular Endothelial Growth Factor Concentration in Vitreous [ Time Frame: Start of surgery. ] [ Designated as safety issue: Yes ]
    Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.

  • Endolaser Photocoagulation [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]
    Number of intraoperative endolaser photocoagulation.

  • Iatrogenic Retinal Tears [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]
    The number of participants who had intraoperative iatrogenic retinal tears.

  • Surgical Time [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]
  • Postoperative Best Corrected Visual Acuity [ Time Frame: 1 mouth after surgery. ] [ Designated as safety issue: Yes ]

    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.


  • Best Corrected Visual Acuity Change [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

    Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.

    The higher values represent a worse outcome.


  • Postoperative Neovascular Glaucoma [ Time Frame: Within 1 month after the surgery. ] [ Designated as safety issue: Yes ]
    The number of participants with progressive or persistent neovascular glaucoma after surgery.

  • Elevated Intraocular Pressure [ Time Frame: Within 1 month after the surgery. ] [ Designated as safety issue: No ]
    The number of participants with elevated intraocular pressure after surgery.

  • Gas Tamponade [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]
    The number of participants with gas tamponade at the end of the surgery.

  • Silicon Oil Tamponade [ Time Frame: End of surgery. ] [ Designated as safety issue: Yes ]
    The number of participants with silicon oil tamponade at the end of the surgery.


Enrollment: 69
Study Start Date: May 2012
Study Completion Date: March 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854593

Locations
Japan
Surugadai Nihon University Hospital
Tokyo, Japan, 101-8309
Sponsors and Collaborators
Nihon University
Investigators
Study Chair: Ayumu Manabe
  More Information

No publications provided

Responsible Party: Ayumu Manabe, Nihon University
ClinicalTrials.gov Identifier: NCT01854593     History of Changes
Other Study ID Numbers: CCT-NAPN-23170
Study First Received: May 13, 2013
Results First Received: December 29, 2013
Last Updated: June 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetic Retinopathy
Hemorrhage
Retinal Detachment
Retinal Diseases
Vitreous Hemorrhage
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Eye Hemorrhage
Pathologic Processes
Vascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014