Table of Contents - WOC 2012

WOC2012 Abstract Book
FP-RET-TH 09 (8)
Efficacy and Safety of 2.0 mg and 0.5 mg Ranibizumab in Patients
with Subfoveal Neovascular Age-Related Macular Degeneration: The
HARBOR Study
Suner Ivan (1) , Yee Murahashi Wendy (2) , Zhengrong Li (2) , Rubio Roman (2)
1. Retina Associates of Florida
2. Genentech, Inc
Purpose: VEGF inhibition with 0.5 mg ranibizumab has demonstrated visual
gains in patients with subfoveal neovascular age-related macular degeneration
(wet AMD). The HARBOR study was a Phase III, prospective, double-masked,
randomized, active-treatment controlled trial designed to evaluate the efficacy
and safety of 2.0 mg ranibizumab compared with 0.5 mg ranibizumab in
patients with wet AMD.
Methods: Patients with subfoveal wet AMD (n=1097) ?50 years of age were
randomized to receive 2.0 mg or 0.5 mg ranibizumab intravitreal injections
dosed monthly or on an as-needed basis (PRN) after three loading doses.
Results: Efficacy and safety outcomes from the HARBOR study at 12 months
will be reported, including mean change from baseline best-corrected Visual
Acuity, mean change from baseline central foveal thickness, mean number
of injections, mean change from baseline macular volume, and incidence of
ocular and nonocular adverse events (AEs) and serious AEs.
Conclusions: The efficacy and safety profile of a higher-dose of ranibizuamb
compared with the currently approved dose in patients with subfoveal wet
AMD, as well as alternate dosing regimens, will be discussed.
Target Audience: Retina Specialists and General Ophthalmologists
Educational Level: Intermediate
FP-RET-TH 09 (9)
Integrated Analysis of the VIEW 1 and VIEW 2 Studies of VEGF Trap-
Eye vs. Ranibizumab in Wet AMD
Chong Victor (1) , Schmidt-Erfurth Ursula (2) , Heier Jeffrey (3) , Anderesi Majid (4) ,
Vitti Robert (5)
1. University of Oxford
2. Ophthalmology Department, Medical University of Vienna
3. Ophthalmic Consultants of Boston
4. Bayer Schering Pharma
5. Regeneron Pharmaceuticals, Inc.
Purpose: Results of two non-inferiority Phase 3 studies were integrated into a
comprehensive dataset (of the largest for wet AMD) for analyzing efficacy and
safety.
Methods: A total 2457 patients from VIEW 1 (North America) and VIEW 2
(Europe, Latin America, and Asia) were randomized to ranibizumab 0.5 mg
monthly (Rq4) or VEGF Trap-Eye (VTE) 2 mg monthly (2q4), 0.5 mg monthly
(0.5q4), or 2 mg every 2 months after 3 initial monthly doses (2q8). The primary
outcome was the proportion of patients who maintained visual acuity (lost