Comparing Bevacizumab PRN and focal/grid laser for naive diabetic macular edema. One year results of an open-label randomized controlled trial

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Quan Nguyen N
Tuan Tran A

Abstract

Background:
Diabetic retinopathy is an emerging challenge and burden worldwide and in Viet Nam. Among those patients, diabetic macular edema (DME) is disabling for patients in working ages. Bevacizumab is a popular anti-VEGF using in DME with a relative safety profile and good efficacy in clinical use. However, clinical randomized trials using Bevacizumab PRN in DME treatment is somewhat lacking, especially in Viet Nam population. We conducted an open-label clinical randomized trial comparing Bevacizumab PRN to modified ETDRS focal/grid laser in treating naive DME patients.
Objectives:
Intravitreal injection of Bevacizumab is non-inferior to modified ETDRS focal/grid laser in treating naive DME using BCVA and central retinal thickness (CRT) change from baseline at 12 months.
Methods:
This was an open-label randomized controlled trial. We recruited type 2 diabetes patients with vision loss from naïve DME having BCVA from 20/25 to 20/320 (Snellen equivalent) and CRT ≥ 225 micron on spectral domain optical coherence tomography. Each eye was randomized to at least 3 monthly intravitreal Bevacizumab (1,25 mg) injections until BCVA stabilization then PRN or standard modified ETDRS focal/grid laser protocol. BCVA change within 5 letters was considered stable. Bevacizumab group was followed up with BCVA and CRT every month while Laser group was followed up every three months and both were treated PRN accordingly.
Results:
There were 112 eyes of 79 patients were randomized (55 to Bevacizumab, 57 to focal/grid laser). Among those eyes, 39.62% bevacizumab-treated eyes vs 8.93% laser-treated eyes gained at least 15 letters at 12 months (p< 0.001). Average letters gained were 12.17 ± 6.65 and 2.11 ± 11.84 accordingly. Average change in CRT were -143.89 ± 127.54 and -89.96 ± 127.62 micron respectively (p< 0.001). No serious systemic adverse events were recorded. The most common adverse event in bevacizumab-treadted patients was subconjunctival hemorrhages 37%.
Conclusions:
Bevacizumab PRN was non-inferior to or better than focal/grid laser in treating naive DME patients in terms of BCVA and RCT change at 12 months.
Keywords:
anti-VEGF, Bevacizumab, Diabetic macula edema, Focal/ grid Laser
Abbreviations
• Best corrected visual acuity (BCVA)
• Central retinal thickness (CRT)
• Spectral domain optical coherence tomography (SD OCT)
Article category:
• Original study
Corresponding author:
• Quan Nguyen N.
• Phone: +84 908489699
• Email: drquan@bvmat.com

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Original Study

References

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