Effect of the Adjunctive IVB Before PRP

Diabetic Retinopathy Clinical Trial

— IVB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504724
• Other study ID #: IVB and PRP
• Status: Completed
• Phase: Phase 4
• First received: January 1, 2012
• Last updated: December 24, 2013
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Dong Ho Park	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness	central macular thickness measured by Cirrus HD optical coherence tomography	6 months after first PRP session	No
Secondary	Retinal nerve fiber layer thickness	retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.	6 months after first PRP session	No