To test the hypothesis that tolerating some subretinal fluid (SRF) in patients with neovascular agerelated macular degeneration (nAMD) treated with ranibizumab using a treat-and-extend (T&E) regimen can achieve similar visual acuity (VA) outcomes as treatment aimed at resolving all SRF.Design: Multicenter, randomized, 24-month, phase 4, single-masked, noninferiority clinical trial.Participants: Participants with treatment-naïve active subfoveal choroidal neovascularization (CNV). Methods: Participants were randomized to receive ranibizumab 0.5 mg monthly until either complete resolution of SRF and intraretinal fluid (IRF; intensive arm: SRF intolerant) or resolution of all IRF only (relaxed arm: SRF tolerant except for SRF >200 mm at the foveal center) before extending treatment intervals. A 5-letter noninferiority margin was applied to the primary outcome.Main Outcome Measures: Mean change in best-corrected VA (BCVA), and central subfield thickness and number of injections from baseline to month 24.Results: Of the 349 participants randomized (intensive arm, n ¼ 174; relaxed arm, n ¼ 175), 279 (79.9%) completed the month 24. The mean change in BCVA from baseline to month 24 was 3.0 letters (standard deviation, 16.3 letters) in the intensive group and 2.6 letters (standard deviation, 16.3 letters) in the relaxed group, demonstrating noninferiority of the relaxed compared with the intensive treatment (P ¼ 0.99). Similar proportions of both groups achieved 20/40 or better VA (53.5% and 56.6%, respectively; P ¼ 0.92) and 20/200 or worse VA (8.7% and 8.1%, respectively; P ¼ 0.52). Participants in the relaxed group received fewer ranibizumab injections over 24 months (mean, 15.8 [standard deviation, 5.9]) than those in the intensive group (mean, 17 [standard deviation, 6.5]; P ¼ 0.001). Significantly more participants in the intensive group never extended beyond 4-week treatment intervals (13.5%) than in the relaxed group (2.8%; P ¼ 0.003), and significantly more participants in the relaxed group extended to and maintained 12-week treatment intervals (29.6%) than the intensive group (15.0%; P ¼ 0.005).Conclusions: Patients treated with a ranibizumab T&E protocol who tolerated some SRF achieved VA that is comparable, with fewer injections, with that achieved when treatment aimed to resolve all SRF completely.
This research establishes a methodological framework for quantifying community resilience based on fluctuations in a population's activity during a natural disaster. Visits to points-of-interests (POIs) over time serve as a proxy for activities to capture the combined effects of perturbations in lifestyles, the built environment and the status of business. This study used digital trace data related to unique visits to POIs in the Houston metropolitan area during Hurricane Harvey in 2017. Resilience metrics in the form of systemic impact, duration of impact, and general resilience (GR) values were examined for the region along with their spatial distributions. The results show that certain categories, such as religious organizations and building material and supplies dealers had better resilience metrics—low systemic impact, short duration of impact, and high GR. Other categories such as medical facilities and entertainment had worse resilience metrics—high systemic impact, long duration of impact and low GR. Spatial analyses revealed that areas in the community with lower levels of resilience metrics also experienced extensive flooding. This insight demonstrates the validity of the approach proposed in this study for quantifying and analysing data for community resilience patterns using digital trace/location-intelligence data related to population activities. While this study focused on the Houston metropolitan area and only analysed one natural hazard, the same approach could be applied to other communities and disaster contexts. Such resilience metrics bring valuable insight into prioritizing resource allocation in the recovery process.
The objective of this article is to systematically assess and identify factors affecting risk disparity due to infrastructure service disruptions in extreme weather events. We propose a household service gap model that characterizes societal risks at the household level by examining service disruptions as threats, level of tolerance of households to disruptions as susceptibility, and experienced hardship as an indicator for the realized impacts of risk. The concept of “zone of tolerance” for the service disruptions was encapsulated to account for different capabilities of the households to endure the adverse impacts. The model was tested and validated in the context of power outages through survey data from the residents of Harris County in the aftermath of Hurricane Harvey in 2017. The results show that households’ need for utility service, preparedness level, the existence of substitutes, possession of social capital, previous experience with disasters, and risk communication affect the zone of tolerance within which households cope with service outages. In addition, sociodemographic characteristics, such as race and residence type, are shown to influence the zone of tolerance, and hence the level of hardship experienced by the affected households. The results reveal that population subgroups show variations in the tolerance level of service disruptions. The findings highlight the importance of integrating social dimensions into the resilience planning of infrastructure systems. The proposed model and results enable human‐centric hazards mitigation and resilience planning to effectively reduce the risk disparity of vulnerable populations to service disruptions in disasters.
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