Effect of the Adjunctive IVB Before PRP

Phase 4

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: bevacizumab

• Registration Number: NCT01504724
• Lead Sponsor: Kyungpook National University Hospital

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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-01-01
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-05
• Primary Completion: 2012-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVB group	bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Central macular thickness	6 months after first PRP session	central macular thickness measured by Cirrus HD optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Retinal nerve fiber layer thickness	6 months after first PRP session	retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.

Trial Locations

Locations (1)

Dong Ho Park; 🇰🇷 Daegu, Korea, Republic of