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Efficacy and Safety of Intravitreal aflibercept in DME: Results of two phase III studies (VIVID-DME and VISTA-DME)

Session Details

Session Title: New drug treatment and technology

Session Date/Time: Friday 27/09/2013 | 14:30-16:00

Paper Time: 15:58

Venue: Hall 3 (Level 0)

First Author: U.Schmidt-Erfurth AUSTRIA

Co Author(s):                  

Abstract Details


Clinically significant diabetic macular edema (DME), which occurs when fluid extravasates into the center of the macula, is a leading cause of vision loss in patients with diabetes. Two phase III studies, VIVID-DME and VISTA-DME, were conducted to determine efficacy and safety of intravitreally administered aflibercept (IVT-AFL) therapy compared to conventional macular laser photocoagulation


Patients with diabetic macular edema with center involvement, in two similarly-designed double-masked, randomized, active-controlled clinical studies. VIVID-DME was carried out in non-US countries, while VISTA-DME was performed exclusively in the US


Patients were randomized 1:1:1 to IVT-AFL 2 mg given every 4 weeks (2q4) plus sham laser or IVT-AFL 2 mg given every 8 weeks (2q8) following 5 initial monthly doses plus sham laser or macular laser treatment plus IVT-sham treatment. The primary endpoint was defined as the change from baseline in best corrected visual acuity (BCVA; change in ETDRS letter score) at Week 52. Secondary endpoints included: 1) proportion of subjects who gained ≥10 or ≥ 15 ETDRS letters from baseline to Week 52; 2) Proportion of subjects with a ≥ two-step improvement in the ETDRS DR severity scale from baseline to Week 52, 3) change in central retinal thickness from baseline to Week 52, as assessed by optical coherence tomography (OCT) and 4) change in visual function from baseline to Week 52, as assessed by the NEI VFQ-25 near and distance activities subscales. Data were analyzed using last observation carried forward (LOCF) for the primary analysis


In VIVID-DME, BCVA in IVT-AFL treated eyes improved by +10.5 letters (2q4) and +10.7 letters (2q8) from baseline to week 52, compared to an increase of only +1.2 letters for laser only (P<0.0001 for both IVT-AFL arms compared to laser). In VISTA-DME, BCVA improved by +12.5 letters (2q4) and +10.7 letters (2q8) compared with stable results with +0.2 letters in the laser group (P<0.0001). IVT-AFL was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the treatment groups and the laser only group. Arterial thromboembolic events as defined by the Anti-Platelet Trialists’ Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) also occurred at similar rates across the treatment groups and the laser control group. AEs were typical of those seen in other studies in patients with diabetes receiving intravitreal anti-VEGF therapy. The most frequent ocular treatment emergent AEs (TEAE) observed in the VIVID-DME and VISTA-DME trials included conjunctival hemorrhage, eye pain, and vitreous floaters. The most frequent non-ocular TEAEs included hypertension and nasopharyngitis, which occurred with similar frequency in the treatment groups and the laser control group


In both phase III studies VIVID-DME and VISTA-DME, aflibercept groups demonstrated significant and robust superiority of BCVA endpoints over laser photocoagulation at week 52 with similar efficacy in the 2q4 and 2q8 treatment groups. IVT-AFL was well tolerated with a safety profile similar to that observed in neovascular age-related macular degeneration and central retinal vein occlusion. Financial Disclosure: The Medical University of Vienna has received contract research recompensation, Ursula Schmidt-Erfurth has served as a consultant for Allergan, Alcon, Bayer HealthCare, Boehringer, Novartis and received travel support for presentation at scientific meetings following the policy of the University.

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