Anatomic Outcomes at 2 Years in the ANCHOR Study Comparing Ranibizumab (LucentisTM) and Verteporfin Photodynamic Therapy (PDT) in Predominantly Classic Neovascular Age-Related Macular Degeneration (AMD)

Abstract

Purpose:: The ANCHOR study compared the efficacy and safety of ranibizumab (Lucentis^TM) versus PDT in patients with predominantly classic, subfoveal choroidal neovascularization (CNV) secondary to AMD. Changes in anatomic characteristics of the CNV lesions, assessed using fluorescein angiography (FA) and optical coherence tomography (OCT), were prespecified secondary or exploratory efficacy outcomes. At 12 months, the visual acuity (VA) benefit of ranibizumab over PDT was reflected in corresponding changes, on average, in several anatomic features of the lesions. We will present anatomic findings from ANCHOR for the entire 2-year study period.

Methods:: ANCHOR was a Phase 3, randomized, multicenter, double-masked trial. 423 patients were randomized 1:1:1 to ranibizumab 0.3 mg + sham PDT, ranibizumab 0.5 mg + sham PDT, or PDT + sham intravitreal injection. Ranibizumab (or sham) injection was administered monthly; PDT (or sham) was administered at study day 0 and then quarterly as needed. FA was done at screening and every 3 months on all patients, and OCT was done at days 0 and 7 and months 1 and 12 on 53 patients at selected study sites. A central reading center assessed all images. Key FA evaluations at 12 and 24 months were mean changes from baseline in: area of classic CNV, total lesion area, total area of CNV, and total area of CNV leakage (including intense, progressive staining of the retinal pigment epithelium). Key OCT evaluations were mean changes from baseline in central foveal retinal thickness and total retinal volume over time up to 12 months.

Results:: At 12 months, all of the key anatomic outcomes favored ranibizumab over PDT and the differences between ranibizumab and PDT treatments were statistically significant (p <0.05). Results for 24 months were not yet available as of the deadline for abstract submission.

Conclusions:: On average, lesion characteristics assessed by FA and OCT were improved with ranibizumab at 12 months. We will present results for the full 24 months.

Clinical Trial:: www.clinicaltrials.gov NCT00061594

Keywords: age-related macular degeneration • choroid: neovascularization • imaging/image analysis: clinical