Effect of the Adjunctive IVB Before PRP

NCT ID: NCT01504724

Last Updated: 2013-12-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-08-31

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

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Avastin; Genentech, Inc., South San Francisco, CA, USA

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Ho Park

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Ho Park, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

Dong Ho Park

Daegu, , South Korea

Countries

South Korea

References

Jo YJ, Heo DW, Shin YI, Kim JY. Diurnal variation of retina thickness measured with time domain and spectral domain optical coherence tomography in healthy subjects. Invest Ophthalmol Vis Sci. 2011 Aug 17;52(9):6497-500. doi: 10.1167/iovs.11-7403.

Reference Type: BACKGROUND

PMID: 21705686 (View on PubMed)

Other Identifiers

IVB and PRP

Identifier Type: -

Identifier Source: org_study_id