Effect of the Adjunctive IVB Before PRP

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01504724

Acronym

IVB

Enrollment

Registered

2012-01-05

Start date

2011-08-31

Completion date

2013-08-31

Last updated

2013-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

Keywords

central macular thickness

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

Interventions

DRUGbevacizumab

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026