Impact of baseline Diabetic Retinopathy Severity Scale scores on visual outcomes in the VIVID-DME and VISTA-DME studies

Abstract

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.

Keywords: angiogenesis; macula; retina; treatment medical.

Conflict of interest statement

Competing interests: GS is a consultant to Novartis, Bayer, Allergan, Genentech, Roche, Heidelberg Engineering, and Alcon. He has also received support for travel to meetings from Bayer HealthCare, Centervue, Heidelberg Engineering, and Novartis. He has received payment for lectures from Zeiss, and is a patent holder in conjunction with Ocular Instruments, Inc. He has received payment for development of educational presentations for Roche. NF is a consultant to Alimera, and has received funding from Novartis, Allergan, Alimera, Bayer, and Heidelberg Engineering. JJA is a member of advisory boards for Novartis, Bayer, and Allergan. She has received personal fees and others from Novartis and others from Bayer. TA Katz is an employee of Bayer. CM is an employee of Bayer. CL is an employee of Bayer. FGH is a consultant to Acucela, Genentech/Roche, Novartis, Bayer, Alcon, OPTOS, Heidelberg Engineering, Carl Zeiss Meditec, Allergan, and Pfizer, and has received financial support from OPTOS, Heidelberg Engineering, Carl Zeiss Meditec, Alcon, Genentech/Roche, Bayer, and Novartis.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

Difference in treatment effect between intravitreal aflibercept and laser (ETDRS letters), adjusting for baseline BCVA at (A) week 52 and (B) week 100. BCVA, best-corrected visual acuity; DRSS, Diabetic Retinopathy Severity Scale; ETDRS, Early Treatment Diabetic Retinopathy Study.

Figure 2

Proportion of patients (A) with ≥2 step improvement in DRSS score by baseline DRSS score at week 52, (B) with ≥2 step improvement in DRSS score by baseline DRSS score at week 100, (C) who gained ≥15 letters in BCVA by baseline DRSS score at week 52, (D) who gained ≥15 letters in BCVA by baseline DRSS score at week 100, (E) who lost >0 letters in BCVA by baseline DRSS score at week 52, and (F) who lost >0 letters in BCVA by baseline DRSS score at week 100. BCVA, best-corrected visual acuity; DRSS, Diabetic Retinopathy Severity Scale.