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Søren Leer Blindbæk, Tunde Peto, Jakob Grauslund; Aflibercept and navigated versus conventional laser in diabetic macular edema: a 12-month prospective, randomized clinical trial.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):2627.
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In center-involved diabetic macular edema (DME), vascular endothelial growth factor (VEGF) inhibitors have replaced retinal laser as first line of treatment given a consistently demonstrated efficacy with visual improvement in most patients. However, a high cost and a substantial number of repetitive injections is a concern. Combination therapy including retinal laser has been proposed, but results are conflicting, and the potential effect of specific photocoagulation systems is unknown.Hence, in a 12-month, randomized clinical trial comparing intravitreal aflibercept and navigated versus conventional laser, we evaluated treatment efficacy and need of intravitreal injections in patients with center-involving DME.
Forty eight eyes of 32 newly referred patients with center-involved DME were randomized 1:1 to receive three monthly injections of 2.0 mg aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser. From month four through twelve, patients were followed monthly and additional intravitreal injections were given. Criteria for re-treatment were central retinal thickness (CRT) > 20% from lowest measurement or loss in BCVA > 5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters as compared to baseline.Sample size calculation stated a minimum 19 eyes in each group.
Baseline median BCVA was 75.0 ETDRS letters and median CRT was 352 µm with no difference between groups. From baseline to month 12, BCVA improved by 8.0 ETDRS and CRT reduced by 80.0 µm with no differences between groups A and B (+10.0 vs +7.0, p=0.18, and -75.5 µm vs -91.0 µm, p=0.18). After laser, median need of additional aflibercept was 1 (1 vs 1, p=0.56) and 39.5% of patients did not need further treatment (41.7% vs 36.8%, p=1.00).
In a randomized, clinical trial, intravitreal aflibercept and timely-delivered focal/grid laser, regardless of type, demonstrated high efficacy and a low need of additional treatment in newly-referred patients with center-involved DME. Compared to e.g. the DRCR.net Protocol I, we achieved similar efficacy with only half the number of intravitreal injections during the first year of treatment. Hence, we recommend implementation of standardized combination therapy to reduce the burden of repetitive injections for both patients and health care systems.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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