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Yuichiro Ogura, Nicolas Feltgen, Jean-Francois Korobelnik, Edoardo Midena, Todd A Katz, Claudia Teukmantel, Carola Metzig, Oliver Zeitz, VIVID-DME and VISTA-DME study investigators; Effect of Baseline Central Retinal Thickness (CRT) and Best Corrected Visual Acuity (BCVA) on Treatment Outcomes With Intravitreal Aflibercept Injection (IAI) or Macular Laser Photocoagulation in Diabetic Macular Edema (DME). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1748.
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© ARVO (1962-2015); The Authors (2016-present)
The VIVID-DME and VISTA-DME clinical trials evaluated the efficacy and safety of IAI vs laser in patients with DME
Patients (N=872) were randomized to IAI 2mg every 4 weeks (2q4) + sham laser, IAI 2mg every 8 weeks (2q8) (after 5 initial monthly doses) + sham laser, or laser + sham injections. Primary endpoint was change from baseline in BCVA to Week 52 (W52). The current pooled VIVID-DME/VISTA-DME analysis examined outcomes at W52 in subgroups of baseline CRT <400µm or ≥400µm (by SD-OCT). The additional impact of baseline BCVA was also assessed within the 2 baseline CRT subgroups.
Mean BCVA changes to W52 for IAI 2q4 and 2q8 vs laser were 10.2 and 10.0 vs 2.9 letters (CRT<400µm; P<0.0001), and 12.1 and 11.0 vs -0.1 letters (CRT≥400µm; P<0.0001). When patient subgroups were further categorized by both CRT and BCVA at baseline, IAI-treated patients consistently experienced greater improvements vs laser-treated patients. In the subgroup with greatest baseline impairment (CRT≥400µm + BCVA<40 letters; n=63), mean BCVA changes for 2q4 and 2q8 vs laser were 18.2 and 18.3 vs -0.6 letters; in the subgroup with least baseline impairment (CRT<400µm + BCVA≥65; n=134), a group not expected to show substantial improvements, mean BCVA changes were +9.5 and +7.6 vs +2.3 letters. Mean changes in CRT to W52 for 2q4 and 2q8 vs laser were -68.7 and -77.9 vs 0.8µm (CRT<400µm; P<0.0001), and -244.2 and -228.6 vs -96.5µm (CRT≥400µm; P<0.0001). Proportions of patients with a ≥2-step improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) to W52 were 31.9% and 29.5% vs 15.0% (CRT<400µm; P≤0.05), and 37.0% and 30.2% vs 11.9% (CRT≥400µm; P<0.01). Cataract (VIVID-DME) and vitreous haemorrhage (VISTA-DME) were the most common ocular SAEs in study eyes treated with IAI (both 2 patients [0.7%]).
These results suggest that the visual, anatomical and DRSS benefits of IAI 2q4 and 2q8 over laser are robust and similar in patient subgroups based on CRT and BCVA at baseline. Moreover, visual benefits appear to be greater with IAI regardless of both CRT and BCVA at baseline. Consistent benefits on the DRSS indicate an effect of IAI not only on DME, but also on the underlying diabetic retinopathy.
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