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NCT Number: NCT01854593

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

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.

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Key information

Conditions

Proliferative Diabetic Retinopathy Diabetic Traction Retinal Detachment Eye Diseases Eye Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Vitreous Hemorrhage

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Surugadai Nihon University Hospital

Tokyo, 101-8309, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)

Other names: Avastin

Vitrectomy

Procedure

vitrectomy of 25 gauge system.

Sham Injection

Device

Sham injection one day before vitrectomy

Primary outcomes

  1. Reoperation

    Time frame: 1 month

    Vitreoretinal reoperation due to recurrent vitreous hemorrhage.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nihon University

Other

Registry information

Official study title

Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
May 15, 2013
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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