Effect of the Adjunctive IVB Before PRP

Kyungpook National University

Status and phase: Completed; Phase 4

Conditions: Diabetic Retinopathy

Treatments: Drug: bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01504724

IVB and PRP

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

IVB group

Experimental group

Description:

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.

Treatment:

Drug: bevacizumab

only PRP group

No Intervention group

Description:

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.