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.

No abstract

No abstract

No abstract

No abstract

No abstract

Objective To describe the incidence and outcomes of endophthalmitis after intravitreal injections of anti-VEGF agents in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT) and to assess the effect of use of prophylactic topical antimicrobials on incidence. Design Cohort study within a randomized clinical trial. Participants Patients enrolled in CATT. Methods Patients with neovascular age-related macular degeneration received intravitreal injections of ranibizumab or bevacizumab under one of three dosing regimens. The study protocol specified pre-injection preparation to include use of a sterile lid speculum and povidone iodine (5%). Use of pre-and post-injection antibiotics was at the discretion of the treating ophthalmologist. Patients were followed monthly for two years. Main Outcome Measures Development of endophthalmitis and visual acuity. Results Endophthalmitis developed after 11 of 18,509 injections (1 per 1,700; 0.06%; 95% Confidence Interval (0.03%, 0.11%)), and among 11 of 1185 patients (0.93%; 95% Confidence Interval (0.52, 1.66)). Incidence of endophthalmitis was 0.15% among injections with no antibiotic use, 0.08% among injections with pre-injection antibiotics only, 0.06% among injections with post-injection antibiotics only, and 0.04% among injections with pre-and post-injection antibiotics (p=0.20). All eyes were treated with intravitreal antibiotics and 4 had vitrectomy. Among the 11 affected eyes, the final study visual acuity was 20/40 or better in 4 (36%) eyes, 20/50-20/80 in 2 (18%) eyes, 20/100-20/160 in 3 (27%) , and <20/800 in 2 (18%) eyes. The final visual acuity was within 2 lines of the visual acuity before endophthalmitis in 5 (45%) eyes. Conclusion Rates of endophthalmitis were low and similar to those in other large scale studies. Use of topical antibiotics either before or after injection does not appear to reduce the risk for endophthalmitis.