Session Title: AMD II
Session Date/Time: Friday 27/09/2013 | 08:00-10:00
Paper Time: 08:48
Venue: Hall 3 (Level 0)
First Author: G.Richard GERMANY
Co Author(s): B. Stemplewitz
Assess efficacy of aflibercept or ranibizumab retreatment in a reactive vs. a proactive treatment schedule in a subgroup of patients who, at Week 96, had lost ≥5 letters from Week 52 in the VIEW studies.
Two double-blinded, randomized, active comparator-controlled, multi-national, 2-year phase 3 studies.
Patients with neovascular age-related macular degeneration (n=2412) were randomized to monthly ranibizumab 0.5 mg (Rq4), monthly aflibercept 2 mg (2q4), monthly aflibercept 0.5 mg (0.5q4), or aflibercept 2 mg every-other-month (2q8) following 3 initial monthly doses. Between Weeks 52 and 96, a minimum of three 2-mg injections were given at 12-week intervals in all treatment arms, but patients could be treated more frequently if pre-specified criteria were met.
After switching to reactive treatment, a loss of ≥5 letters at Week 96 from Week 52 was observed in 20.3%, 20.6%, 21.4% and 20.0% patients in the Rq4, 2q4, 0.5q4 and 2q8 groups, respectively. Mean number of injections from Week 52 to 96, in the subgroup of patients who, at Week 96, had lost ≥5 letters from Week 52, was 4.8, 4.2, 4.8 and 4.3 in the Rq4, 2q4, 0.5q4 and 2q8 groups. Mean change in visual acuity from baseline to Week 52 in this subset of patients was 8.6, 8.9, 10.3, and 8.5 letters in the Rq4, 2q4, 0.5q4 and 2q8 groups. From baseline to Week 96, mean change in visual acuity was 3.1, 3.4, -2.5, and -3.8 letters. Mean change in central retinal thickness (CRT) from baseline to week 52 was -109.7, -134.4, -121.1, and -139.5 µm in the Rq4, 2q4, 0.5q4 and 2q8 groups. From baseline to Week 96, the mean change in CRT was -80.1, 115.7, -108.5, and -133.1 µm. In general, more patients had retinal fluid on OCT at Week 96 compared to Week 12. The most frequent ocular adverse events (>10% of patients) were conjunctival hemorrhage, eye pain, retinal hemorrhage, and reduced visual acuity.
A subset of patients lost vision after the switch from proactive to reactive treatment with either aflibercept or ranibizumab. However, CRT changes neither preceded nor paralleled changes in best-corrected visual acuity. Further research is required to determine the critical magnitude and duration of CRT increase that is associated with visual acuity deterioration. This study demonstrates that a proactive, schedule-based dosing regimen can effectively preserve vision in neovascular age-related macular degeneration.