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Shilpa Desai, Robert B Bhisitkul, Wayne Enoria, Soraya Rofagha, David S Boyer, Srinivas R Sadda, Kang Zhang; Visual outcomes and macular atrophy in non-study eyes in ANCHOR/MARINA subjects (SEVEN-UP Study). Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):2836.
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To compare long-term visual outcomes and macular atrophy in fellow eyes from a cohort of AMD patients who participated in the ANCHOR, MARINA, and HORIZON trials.
Sixty-five patients with exudative AMD were evaluated in a prospective, uncontrolled, non-interventional study to measure the efficacy of ranibizumab. In ANCHOR/MARINA, “study eyes” underwent a protocol of monthly ranibizumab injections for 2 years. “Fellow eyes” received no treatment. At a mean of 7 years after study entry, patients were recruited for a single update visit to evaluate vision and collect fluorescein angiography (FA) and fundus autofluorescence (FAF). Macular atrophy area was measured in a masked, independent fashion from analysis of FA and FAF. Fellow eyes were divided into three sub-groups based on exudative status. Statistical analyses were performed using Spearman Rank Correlation.
In fifty subjects for whom fellow eye data was available, at year 7, study eyes had an average ETDRS vision score of 45.1±25.6 letters, and mean macular atrophy of 2.8±2.20 mm2. Fellow eyes overall had a mean ETDRS score of 50.5±27.8 letters, a decline from 60.1±12.4 letters at Day 0. For Year 7 outcomes in the fellow eye subgroups, eyes with exudative AMD from day 0 (N = 17) had mean vision of 27.3±19.0 letters, and macular atrophy area of 5.75±2.52 mm2, having received only 3.33±7.06 anti-VEGF injections since HORIZON Study exit. Fellow eyes that converted to exudative AMD during the 7-year period (N = 15) had mean vision of 65.1±15.6 letters, macular atrophy area of 2.67±2.78 mm2, and received 11.3±8.08 anti-VEGF injections. Finally, fellow eyes that remained dry throughout the 7-year period (N = 16) had mean vision of 68.6±24.3 letters and macular atrophy area of 1.07±1.67 mm2. A statistically significant relationship between the mean macular atrophy area and the EDTRS letters was found; P < 0.001, slope = -6.96.
Over a 7-year interval since entry into the ANCHOR/MARINA trials, fellow eyes, which could be treated with anti-VEGF after Year 2, showed an overall 10-letter visual decline. Compared to study eyes receiving monthly ranibizumab for 2 years, the subgroup of fellow eyes with exudative AMD duration of 7 years or more had worse vision outcomes and macular atrophy severity. In fellow eyes overall, a greater area of macular atrophy was a significant determinant of decreased long-term vision outcomes.
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