PT  - JOURNAL ARTICLE
AU  - Giovanni Staurenghi
AU  - Nicolas Feltgen
AU  - Jennifer J Arnold
AU  - Todd A Katz
AU  - Carola Metzig
AU  - Chengxing Lu
AU  - Frank G Holz
ED  - ,
TI  - Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies
AID  - 10.1136/bjophthalmol-2017-310664
DP  - 2017 Oct 19
TA  - British Journal of Ophthalmology
PG  - bjophthalmol-2017-310664
4099  - http://bjo.bmj.com/content/early/2017/10/19/bjophthalmol-2017-310664.short
4100  - http://bjo.bmj.com/content/early/2017/10/19/bjophthalmol-2017-310664.full
AB  - Background/aims To evaluate intravitreal aflibercept versus laser in subgroups of patients with baseline Diabetic Retinopathy Severity Scale (DRSS) scores ≤43, 47, and ≥53 in VIVID-DME and VISTA-DME.Methods Patients with diabetic macular oedema were randomised to receive intravitreal aflibercept 2 mg every 4 weeks (2q4), intravitreal aflibercept 2 mg every 8 weeks after five initial monthly doses (2q8), or macular laser photocoagulation at baseline with sham injections at every visit. These post hoc analyses evaluate outcomes based on baseline DRSS scores in patients in the integrated dataset. The 2q4 and 2q8 treatment groups were also pooled.Results 748 patients had a baseline DRSS score based on fundus photographs (≤43, n=301; 47, n=153; ≥53, n=294). At week 100, the least squares mean difference between treatment groups (effect of intravitreal aflibercept above that of laser, adjusting for baseline best-corrected visual acuity) was 8.9 (95% CI 5.99 to 11.81), 9.7 (95% CI 5.54 to 13.91), and 11.0 (95% CI 7.96 to 14.1) letters in those with baseline DRSS scores ≤43, 47, and ≥53, respectively. The proportions of patients with ≥2 step DRSS score improvement were greater in the intravitreal aflibercept group versus laser, respectively, for those with baseline DRSS scores of ≤43 (13% vs 5.9%), 47 (25.8% vs 4.5%), and ≥53 (64.5% vs 28.4%).Conclusions Regardless of baseline DRSS score, functional outcomes were superior in intravitreal aflibercept-treated patients, demonstrating consistent treatment benefit across various baseline levels of retinopathy.Trial registration numbers NCT01331681 and NCT01363440, Post-results.