Objective To evaluate the association of subretinal hyper-reflective material (SHRM) with visual acuity (VA), geographic atrophy (GA) and scar in the Comparison of Age related Macular Degeneration Treatments Trials (CATT) Design Prospective cohort study within a randomized clinical trial. Participants The 1185 participants in CATT. Methods Participants were randomly assigned to ranibizumab or bevacizumab treatment monthly or as-needed. Masked readers graded scar and GA on fundus photography and fluorescein angiography images, SHRM on time domain (TD) and spectral domain (SD) optical coherence tomography (OCT) throughout 104 weeks. Measurements of SHRM height and width in the fovea, within the center 1mm2, or outside the center 1mm2 were obtained on SD-OCT images at 56 (n=76) and 104 (n=66) weeks. VA was measured by certified examiners. Main Outcome Measures SHRM presence, location and size, and associations with VA, scar, and GA. Results Among all CATT participants, the percentage with SHRM at enrollment was 77%, decreasing to 68% at 4 weeks after treatment and 54% at 104 weeks. At 104 weeks, scar was present more often in eyes with persistent SHRM than eyes with SHRM that resolved (64% vs. 31%; p<0.0001). Among eyes with detailed evaluation of SHRM at weeks 56 (n=76) and 104 (n=66), mean [SE] VA letter score was 73.5 [2.8], 73.1 [3.4], 65.3 [3.5], and 63.9 [3.7] when SHRM was absent, present outside the central 1mm2, present within the central 1mm2 but not the foveal center, or present at the foveal center (p=0.02). SHRM was present at the foveal center in 43 (30%), within the central 1mm2 in 21 (15%) and outside the central 1mm2 in 19 (13%). When SHRM was present, the median maximum height in microns under the fovea, within the central 1 mm2 including the fovea and anywhere within the scan was 86; 120; and 122, respectively. VA was decreased with greater SHRM height and width (p<0.05). Conclusions SHRM is common in eyes with NVAMD and often persists after anti-VEGF treatment. At 2 years, eyes with scar were more likely to have SHRM than other eyes. Greater SHRM height and width were associated with worse VA. SHRM is an important morphological biomarker in eyes with NVAMD.

Analyses of AREDS2 data on natural history of GA provide representative data on GA evolution and enlargement. GA enlargement, which was influenced by lesion features, was relentless, resulting in rapid central vision loss. The genetic variants associated with faster enlargement were partially distinct from those associated with risk of incident GA. These findings are relevant to further investigations of GA pathogenesis and clinical trial planning.

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OBJECTIVE To report Reading Center reproducibility during grading of Optical Coherence Tomography (OCT, Carl Zeiss Meditec, Dublin, California) images obtained during the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). DESIGN Prospective clinical trial PARTICIPANTS Independent reading teams reevaluated 270 OCT scans randomly sampled from the first 2 years of CATT enrollment. To assess temporal drift, a cohort of 23 scans submitted during the initial portion of the CATT study was longitudinally followed with serial reproducibility analysis. INTERVENTION CATT readers performed standardized grading on OCT images. A reader team, composed of two independent readers and a Senior Reader, evaluated each scan. Grading included the CATT OCT endpoints of total thickness at the foveal center point and intraretinal fluid, subretinal fluid, and sub-retinal pigment epithelium (RPE) fluid. Independent reading teams masked to the results of initial grading reevaluated scans to determine reproducibility of qualitative grading and measurements. MAIN OUTCOME MEASURES Categorical grading agreement was reported using percent agreement and kappa statistic and measurement agreement was reported using intraclass correlations and paired differences. RESULTS Reading Center teams reproducibly graded intraretinal fluid (percent agreement = 73%, kappa = 0.48, 95% confidence interval or CI 0.38 to 0.58), subretinal fluid (percent agreement = 90%, kappa = 0.80, 95% CI 0.73 to 0.87), and sub-RPE fluid (percent agreement 88%, kappa = 0.75, 95% CI 0.67 to 0.83). For independent Reading Center team measurements of total thickness at the foveal center point, the intraclass correlation was 0.99 (95% CI 0.99 to 0.99, and the mean paired difference between Reading Center teams was −4 micrometers (95% limits of agreement −55 to 47 micrometers). There was no qualitative or quantitative grading drift. CONCLUSIONS The standardized protocols used to evaluate OCT scans from the CATT study were reproducible. The methods used are suitable to monitor OCT imaging data from a large neovascular age related macular degeneration interventional multicenter study.

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There was increased resistance of gram-positive organisms to ciprofloxacin and cefazolin, but not gentamicin, in the two examined time periods. Increased resistance to these commonly used antibiotics emphasizes the need for close follow-up after initial empiric treatment, and maintaining a low threshold for selecting alternative therapy.