ABSTRACT NUMBER - 2402

INTRAVITREAL AFLIBERCEPT VERSUS RANIBIZUMAB FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: 52-WEEK SUBGROUP ANALYSES FROM THE COMBINED VIEW STUDIES


Paul Mitchell

Meeting:  2012 RANZCO


SESSION INFORMATION

Date: 27 Nov 2012

Session Title: FREE PAPERS

Session Time: 2:00 pm - 3:30 pm

Purpose:
To describe various subgroups as defined by certain baseline characteristics from the VIEW Phase 3 program, which showed non-inferiority of aflibercept to ranibizumab on the primary endpoint (proportion of patients experiencing loss of <15 ETDRS letters at Week 52). Methods: In VIEW 1 and VIEW 2 studies, patients with neovascular AMD were randomized to monthly ranibizumab 0.5 mg (Rq4), monthly aflibercept 2 mg (A2q4), monthly aflibercept 0.5 mg (A0.5q4), or aflibercept 2 mg every 2 months (A2q8) following 3 initial monthly doses. Integrated subgroup analyses of the 2 VIEW studies at Week 52 were performed. Results: 23.9% (576/2412), 31.3% (754/2512), and 34.4% (829/2412) of patients presented with predom-inantly classic, minimally classic, and occult lesions at baseline, respectively. The largest gains in best cor-rected visual acuity (BCVA) were seen for those patients with predominantly classic lesions (+10.0, +12.4, +9.2, and +9.8 letters for ranibizumab, Rq4, aflibercept 2q4, aflibercept 0.5q4, and aflibercetp 2q8, respectively). Patients with minimally classic (+7.5–9.6 letters) and occult lesions (+6.7–8.6 letters) had smaller gains. Most (67.5%, 1627/2412) presented with lesions that were ?10.16 mm2 (equivalent to 4 disc areas), with 22.2% (535/2412) having larger lesions. BCVA gains were greater in patients with smaller lesions (+9.4, 10.3, 8.7, and 9.3 letters for Rq4, A2q4, A0.5q4, and A2q8, respectively). Patients with larger lesions gained +6.0–7.1 letters. Conclusion: BCVA outcomes for subgroups stratified by baseline lesion type and size yielded results consis-tent with those of the overall VIEW study population. Aflibercept had a favourable safety profile. When translated into practice, an every-other-month afliber-cept regimen would potentially allow for fewer visits versus established anti-VEGF therapies.