Effect of the Adjunctive IVB Before PRP (IVB)

December 24, 2013 updated by: Dong Ho Park, Kyungpook National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: bevacizumab
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
NO_INTERVENTION: only PRP group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central macular thickness
Time Frame: 6 months after first PRP session
central macular thickness measured by Cirrus HD optical coherence tomography
6 months after first PRP session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after first PRP session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

January 1, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (ESTIMATE)

January 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVB and PRP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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