Abstract
Purpose:
To identify changes in the size and anatomic location of choroidal neovascularization (CNV) at Month 12 in the HARBOR study.
Methods:
This sub-analysis of the HARBOR study included wet AMD patients ≥50 years who were randomized to receive intravitreal injections of ranibizumab 0.5 mg or 2.0 mg monthly (M) or PRN after 3 monthly loading doses (n=1097). CNV location (extrafoveal, juxtafoveal, or subfoveal) and change in total CNV area were evaluated by fluorescein angiography at baseline, months 3, 6, and 12 (graded by a masked central reading center). Observed changes in total CNV area were summarized over 12 months.
Results:
At baseline, the total area of CNV was 3.27 (0.5 mg M, N=275), 3.04 (0.5 mg PRN, n=275), 3.29 (2 mg M, n=274), and 3.17 (2 mg PRN, n=273) disc areas (DAs; 1 DA = 2.54 mm2; as determined by masked grading of fluorescein angiography). Marked reductions in total CNV lesion sizes were observed starting at Month 3 in the monthly (0.5 mg, -1.59; 2 mg -1.82) and PRN groups (0.5 mg, -1.38; 2 mg, -1.73) and continued through Month 12 (monthly: 0.5 mg, -2.19; 2 mg, -2.54; PRN: 0.5 mg, -1.80, 2 mg, -2.02). At 12 months, complete regression in total CNV area (reduction of 100% in the total CNV area from baseline) was observed in 66% of patients in the monthly groups compared with 55% in the PRN groups, while complete regression in classic CNV area was seen in 97% of patients in all groups.
Conclusions:
Ranibizumab treatment (monthly or PRN) induced reductions in total CNV area as measured by fluorescein angiography that differed based on location and type of CNV. Monthly treatment led to greater reduction in total CNV area; however, complete regression in total CNV area was also observed in greater than 50% of patients in the PRN groups.
Keywords: 412 age-related macular degeneration •
748 vascular endothelial growth factor •
466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials