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D. M. Brown, SAILOR Study, S. Francom; Correlation of Qualitative and Quantitative OCT With Visual Acuity Outcomes in Treatment-Naïve Patients in the SAILOR 1 Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5246.
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To assess optical coherence tomography (OCT) findings and correlation with visual acuity (VA) in treatment-naïve patients (pts) in Cohort 1 of SAILOR (phase 3b, ranibizumab in neovascular AMD).
Pts received 0.3 or 0.5 mg ranibizumab (3 monthly doses and PRN thereafter). Central foveal thickness (CFT) was determined by manual caliper measurements from the fast macular thickness map at a central reading center. A subset of 54 treatment-naïve pts with 6 high-resolution macular thickness map images was chosen for a qualitative OCT analysis (>3800 scans). Pts were graded by a single masked reader and divided into 3 groups (no fluid: pts with resolution of all fluid; recurrent fluid: pts who were initially dry, then treated whenever there was OCT evidence of fluid; persistent fluid: pts whose eye never dried or who had fluid on OCT but were not treated because the OCT change did not meet the retreatment criterion). An outcome measure of interest was mean VA change after 12 months’ treatment.
In all treatment-naïve pts at 12 months, the mean decrease (± SEM) in CFT was 72 ± 6 and 92 ± 6 µm for the 0.3 and 0.5 mg groups, respectively; the correlation coefficients between changes from baseline in VA and CFT (12 months) were modest (–0.21 and –0.18 for the 0.3 and 0.5 mg groups, respectively). A subset of 54 patients with baseline characteristics similar to those of the overall treatment-naïve group of Cohort 1 included 7 pts with no fluid, 9 with recurrent fluid, and 38 with persistent fluid. At 12 months, the mean change (± SEM) in VA (letter score) from baseline was 7.4 ± 2.8, –0.33 ± 5.6, and 2.0 ± 2.4 for these groups, respectively. Progressive foveal atrophy was demonstrated in pts who had multiple episodes of fluid recurrence.
Quantitative CFT improved, but correlation with VA changes was modest. Qualitative OCT analysis demonstrated that VA outcomes are better overall when the retina is kept dry and that the presence of fluid (even below the retreatment criterion level) may compromise VA. Progressive foveal atrophy observed after multiple episodes of fluid recurrence may be potentially responsible for the loss of VA gains over time.
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