Abstract
Purpose: :
To assess long-term visual outcomes, disease activity, and treatment status in a cohort of exudative AMD patients from the ANCHOR/MARINA trials.
Methods: :
Fourteen U.S. clinical trial sites recruited 65 patients originally treated in the ANCHOR and MARINA trials (enrolled between March 2003 and September 2004) with further RZB treatment in the HORIZON extension study. In this non-interventional, uncontrolled, cross-sectional study, patients were re-evaluated with ETDRS vision, complete ophthalmologic exam, retinal imaging (fundus photos, fluorescein angiogram, spectral domain OCT, fundus autofluorescence) with analysis by the Doheny Reading Center, and serum collection for genetic studies.
Results: :
At this point, the cohort is 7 to 8 years after initiation of ranibizumab treatment. For the primary endpoint, 37% of original study eyes had ETDRS visual acuity of 20/70 or better. The mean visual acuity in study eyes was 20/125. Within the cohort, subgroups showed favorable outcomes, with good vision (≥20/40) in 23% of eyes, and durable CNV quiescence in 35%. By contrast, another group showed poor outcomes; 37% of eyes had vision of 20/200 or worse. Ongoing exudative disease activity, defined as evidence of CNV leakage or hemorrhage at study visit or within the previous 6 months, was found in 54% of study eyes, and 23% required ongoing treatment (RZB or other AMD treatments). Furthermore, evaluation of the non-study fellow eyes showed 51% of patients had bilateral exudative AMD, with 20% of fellow eyes also receiving current or recent AMD treatments. Six percent of patients were legally blind (20/200 or worse) in both eyes. Genetic analysis of the cohort confirmed a strong association of risk alleles of HTRA1 and CFH.
Conclusions: :
This cohort, representing some of the earliest patients treated with intravitreal RZB, showed distinct outcome categories 7 to 8 years after initiation of RZB treatment ANCHOR or MARINA and in HORIZON. A minority of study eyes had excellent visual outcomes, while a majority have poor visual outcomes and ongoing AMD disease activity requiring treatment. With RZB therapy for exudative AMD, clinical vigilance and prolonged treatment may be required in some patients for 7 years or longer.
Keywords: vascular endothelial growth factor • age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials