Combination of Ranibizumab and Navigated Retinal Photocoagulation in Diabetic Macular Edema, compared to Ranibizumab Mono-Therapy: Twelve Month Results

Abstract

Purpose: The purpose of this study is to evaluate the impact of navigated retinal photocoagulation on the number of intravitreal anti-VEGF injections necessary to maintain visual gain in patients with diabetic macular edema (DME), compared to anti-VEGF mono-therapy.

Methods: A consecutive series of 76 eyes with DME were included and randomized into 3 groups: 1. Ranibizumab monotherapy (n=27; using an observation and retreatment paradigm for anti-VEGF therapy that is compliant with the European Public Assessment Report (EPAR, European Medicines Agency) for ranibizumab), 2. Three consecutive monthly ranibizumab injections followed by navigated laser therapy, then application of the observation and retreatment paradigm as in group “1” (n=15), 3. Monthly ranibizumab injection until central retinal thickness (CRT) was reduced to 450µm (Spectralis OCT) then navigated laser therapy followed by the application of the observation and retreatment paradigm as in group “1” (n=34). Subjects were followed monthly (best corrected Visual acuity (BCVA), CRT) for 12month, to assess the number of anti-VEGF injections required to maintain stable clinical improvement.

Results: After 12 month BCVA increased and in all three investigated groups significantly (group 1: 6.3 ±6.77; group 2: 7.1 ±8.22; group 3: 7.4 ±7.53 letters). To achieve these results, after an upload of three consecutive monthly applied ranibizumab injections, ranibizumab mono-therapy group (group 1) needed 5.2 ± 3.2 injections. In contrast, group 2 and 3 nedded significantly less ranibizumab injections (0.5 ± 0.8 and 0.8 ± 1.1, p<0.001).

Conclusions: In this study, additional navigated laser therapy applied after 3 initial anti-VEGF injections in DME patients was effective in preserving visual gains, comparable to anti-VEGF mono-therapy. In addition, navigated macular laser reduced the number of injections needed significantly.

Keywords: 499 diabetic retinopathy • 688 retina • 578 laser