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Clinical Trials/NCT01504724
NCT01504724
Completed
Phase 4

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

Kyungpook National University Hospital1 site in 1 country30 target enrollmentAugust 2011
Interventionsbevacizumab

Overview

Phase
Phase 4
Intervention
bevacizumab
Conditions
Diabetic Retinopathy
Sponsor
Kyungpook National University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Central macular thickness
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dong Ho Park

Clinical professor

Kyungpook National University Hospital

Eligibility Criteria

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.

Arms & Interventions

IVB group

Patients were treated with IVB injections approximately within 1 week before the first PRP. Then patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.

Intervention: bevacizumab

Outcomes

Primary Outcomes

Central macular thickness

Time Frame: 6 months after first PRP session

central macular thickness measured by Cirrus HD optical coherence tomography

Secondary Outcomes

  • Retinal nerve fiber layer thickness(6 months after first PRP session)

Study Sites (1)

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