Session Title: Vascular Diseases and Diabetic Retinopathy I
Session Date/Time: Thursday 11/09/2014 | 08:00-10:00
Paper Time: 08:48
Venue: Boulevard C
First Author: : E.Midena ITALY
Co Author(s): : J-F Korobelnik
The VIVID-DME and VISTA-DME trials were undertaken to evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) compared with macular laser photocoagulation in patients with DME. The current analyses evaluate the use of additional (rescue) treatments in patients treated with IVT-AFL compared with laser.
VIVID-DME and VISTA-DME were two similarly-designed, double-masked, phase 3 trials that randomized and treated 402 and 461 patients with DME, respectively.
Patients were randomised 1:1:1 to IVT-AFL 2 mg every 4 weeks (2q4) plus sham laser, IVT-AFL 2 mg every 8 weeks (2q8) (after 5 initial monthly doses) plus sham laser, or macular laser photocoagulation (laser) plus sham injections. The primary efficacy endpoint was the mean change from baseline in best corrected visual acuity (BCVA) at week 52.
The mean BCVA gain from baseline to week 52 in the 2q4 and 2q8 groups vs the laser group was 10.5 and 10.7 vs 1.2 letters (P<.0001) in VIVID-DME, and 12.5 and 10.7 vs 0.2 letters (P<.0001) in VISTA-DME, respectively. The corresponding proportion of patients who gained ≥15 letters from baseline at week 52 was 32.4% and 33.3% vs 9.1% (P<.0001) in VIVID-DME, and 41.6% and 31.1% vs 7.8% (P<.0001) in VISTA-DME, respectively. The mean BCVA gain from baseline to week 100 in the 2q4 and 2q8 groups vs the laser group was 11.5 and 11.1 vs 0.9 letters (P<.0001) in VISTA-DME. The most frequent ocular adverse events (AEs) in the IVT-AFL groups in VIVID-DME (52 weeks) were conjunctival hemorrhage, eye pain, and vitreous floaters, while in VISTA-DME (100 weeks) they were cataract, vitreous haemorrhage, and reduced visual acuity. The overall incidence of ocular and non-ocular AEs and serious AEs, including the Anti-Platelet Trialists’ Collaboration (APTC)-defined arterial thromboembolic events, was similar across treatment groups in VIVID-DME (100 weeks) and VISTA-DME (100 weeks).
In both VIVID-DME and VISTA-DME, IVT-AFL demonstrated superiority in visual endpoints over laser at week 52, with similar efficacy in the 2q4 and 2q8 groups. In VISTA-DME, BCVA gains from baseline with both IVT-AFL regimens were sustained through week 100, compared with laser. IVT-AFL was generally well tolerated with no overall difference between treatment groups in serious systemic AEs, including APTC events.