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.
Objective To compare baseline characteristics, treatment frequency, visual acuity (VA), and morphologic outcomes of eyes with > 50% of the lesion composed of blood (B50 group) versus all other eyes (Other group) enrolled in the Comparison of Age-related Macular Degeneration (AMD) Treatments Trials (CATT). Design Prospective cohort study within a multicenter randomized clinical trial. Participants CATT patients with neovascular AMD. Methods Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to three different regimens for dosing over a two-year period. Reading center graders evaluated baseline and follow-up morphology in color fundus photographs (CFP), fluorescein angiograms (FA), and optical coherence tomography (OCT). Masked examiners tested VA. Main Outcome Measures VA and morphologic features at 1 and 2 years. Results The B50 group consisted of 84 (7.1%) of 1185 patients enrolled in CATT. The baseline lesion characteristics of the B50 group differed from the Other group. In the B50 group, CNV size was smaller (0.73 vs 1.83 Disc Areas (DA); p <0.001), total lesion size was greater (4.55 vs 2.31 DA; p <0.001), total retinal thickness was greater (524 vs 455 um; p=0.02), and mean VA was worse (56.0 vs. 60.9 letters, p=0.002). Increases in mean VA were similar in the B50 and Other groups at 1 year (+9.3 vs. +7.2 letters, p=0.22) and at 2 years (9.0 vs. 6.1 letters, p=0.17). Eyes treated PRN received a similar number of injections in the two groups (12.2 vs 13.4, p=0.27). Mean lesion size in the B50 group decreased by 1.2 DA at both 1 and 2 years (primarily due to resolution of hemorrhage) and increased in the Other group by 0.33 DA at 1 year and 0.91 DA at 2 years (p<0.001). Leakage on FA and fluid on OCT were similar between groups at 1 and 2 years. Conclusion In CATT, the B50 group had a visual prognosis similar to the Other group. Lesion size decreased markedly through 2 years. Eyes like those enrolled in CATT with neovascular AMD lesions composed of >50% blood can be managed similarly to those with less or no blood.
Pars plana vitrectomy is both efficacious and safe an option for patients with ERMs and good preoperative vision. Eyes with an ERM and vision 20/50 or better had a statistically significant improvement in the final visual outcome after small-gauge pars plana vitrectomy surgery. As with large-gauge vitrectomy, cataract formation occurred in most phakic eyes within the first year after surgery.
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