Alone laser versus bevacizumab plus laser for diffuse diabetic macular edema (ALBA randomized trial)

Alicia Pareja-Ríos, Elena de Armas-Ramos, Ana Aldea-Perona, Sergio Bonaque-González, Alicia Pareja-Ríos, Elena de Armas-Ramos, Ana Aldea-Perona, Sergio Bonaque-González

Abstract

Purpose: To report the 12-month results of laser (treatment G1) versus intravitreal bevacizumab combined with laser (treatment G2) in patients with diffuse diabetic macular edema (DME).

Methods: In this single-center randomized independent controlled trial, 32 patients were randomized to G1 (n = 15) or G2 (n = 17). In G1, laser was given at baseline and then pro re nata (PRN). In G2, three intravitreal bevacizumab (1.25 mg) injections were given once every 6 weeks, then laser and then PRN. Analysis was performed by treatment as administered. This study was registered in clinicaltrials.gov as NCT01572350 and EU Clinical Trial Registry as 2009-014654-15.

Results: G2 was superior to G1 improving best corrected visual acuity (BCVA) with respect baseline (+8.0 vs + 3.0; p < 0.01). At month 12, a significantly greater proportion of patients had a BCVA letter score >15 and >73 in G2 (3 of 15 (20%) and 8 of 15 (53%), respectively) versus G1 (1 of 17 (6%) and 4 of 18 (23%), respectively). Health-related quality of life, assessed through National Eye Institute Visual Function Questionnaire, at 12 months was statistically indistinguishable between both groups.

Conclusion: G2 provided superior visual acuity gains over G1 in patients with visual impairment due to center-involving diffuse DME, associated with significant gains in VFQ-25 scores.

Keywords: bevacizumab; diabetes mellitus; intravitreal injections; macular edema; off-label use.

Conflict of interest statement

Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

© The Author(s), 2021.

Figures

Figure 1.
Figure 1.
Flow diagram of the study.

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Source: PubMed

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