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OpenTrials
Completed

NCT Number: NCT01504724

Effect of the Adjunctive IVB Before PRP

This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dong Ho Park

Daegu, 700-721, South Korea

About this study

This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with severe NPDR or early PDR without macular edema
  • best-corrected visual acuity (BCVA) of 20/25 or better
  • patients who were followed up for at least 6 months after the first PRP.

Exclusion criteria

  • patients with retinal or choroidal diseases except diabetic retinopathy
  • contraindications to fluorescein angiography (FA) or bevacizumab
  • patients who had previous treatments including anti-angiogenic medications and laser photocoagulation
  • patients with previous vitrectomy
  • patients with uncontrolled hypertension, a recent myocardial infarction or cerebral vascular accidents.

Treatment and study plan

Bevacizumab

Drug

intravitreal bevacizumab injection (1.25 mg/0.05 mL) was done 4.0 mm posterior to the corneal limbus using a 30-gauge needle after topical anesthesia

Other names: Avastin; Genentech, Inc., South San Francisco, CA, USA

Primary outcomes

  1. Central macular thickness

    Time frame: 6 months after first PRP session

    central macular thickness measured by Cirrus HD optical coherence tomography

Secondary outcomes

  1. Retinal nerve fiber layer thickness

    Time frame: 6 months after first PRP session

    retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness

Acronym: IVB

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jan 5, 2012
Registry last updated
Dec 25, 2013

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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