Effect of the Adjunctive IVB Before PRP

NCT01504724 | Completed Phase 4 DMC

• 1 other identifier: IVB and PRP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

central macular thickness

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

  central macular thickness measured by Cirrus HD optical coherence tomography

  6 months after first PRP session

Secondary Outcomes (1)

• Retinal nerve fiber layer thickness

  6 months after first PRP session

Study Arms (2)

IVB group

EXPERIMENTAL

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

only PRP group

NO INTERVENTION

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.

Interventions

bevacizumab 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

Also known as: Avastin; Genentech, Inc., South San Francisco, CA, USA

IVB group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Dong Ho Park

Daegu, 700-721, South Korea

Location

Related Publications (1)

• 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.

  PMID: 21705686 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dong Ho Park, M.D.

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: January 1, 2012
• First Posted: January 5, 2012
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2013
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (1)