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.
Objective: To examine overweight and obesity in Australian children followed through to adulthood. Design and participants: A cohort study of 8498 children aged 7–15 years who participated in the 1985 Australian Schools Health and Fitness Survey; of these, 2208 men and 2363 women completed a follow‐up questionnaire at age 24–34 years in 2001–2005. Main outcome measures: Height and weight were measured in 1985, and self‐reported at follow‐up. The accuracy of self‐reported data was checked in 1185 participants. Overweight and obesity in childhood were defined according to international standard definitions for body mass index (BMI), and, in adulthood, as a BMI of 25–29.9 and ≥ 30 kg/m2, respectively, after correcting for self‐report error. Results: In those with baseline and follow‐up data, the prevalence of overweight and obesity in childhood was 8.3% and 1.5% in boys and 9.7% and 1.4% in girls, respectively. At follow‐up, the prevalence was 40.1% and 13.0% in men and 19.7% and 11.7% in women. The relative risk (RR) of becoming an obese adult was significantly greater for those who had been obese as children compared with those who had been a healthy weight (RR = 4.7; 95% CI, 3.0–7.2 for boys and RR = 9.2; 95% CI, 6.9–12.3 for girls). The proportion of adult obesity attributable to childhood obesity was 6.4% in males and 12.6% in females. Conclusion: Obesity in childhood was strongly predictive of obesity in early adulthood, but most obese young adults were a healthy weight as children.
Introduction: Treat-and-extend (T&E) and pro re nata (PRN; 'as needed') regimens of intravitreal anti-vascular endothelial growth factor (VEGF) treatment have been found to reduce the injection burden on patients and improve the cost effectiveness of the treatment of macular edema. The aim of this study was to assess the effectiveness of a T&E regimen of aflibercept, in a clinical setting, in patients with diabetic macular edema (DME) who were either intravitreal anti-VEGF therapy naive or with minimal exposure to anti-VEGF (B 6 treatments) in the previous 12 months. Methods: This prospective, single arm, open label study recruited patients with DME (macular thickness of C 300 lm) and best-corrected visual acuity (BCVA) between 28-78 ETDRS letters. Participants received five loading doses of intravitreal aflibercept at 4-weekly intervals. BCVA measurements and macular optical coherence tomography were performed at each visit. If no disease activity was detected, treatment intervals were increased by 2 weeks to a maximum of 12 weeks. Outcome measures included: changes in BCVA and retinal anatomical measures (central foveal thickness [CFT] and central macular volume within 6 mm of the fovea [CSVol]) between baseline and 2 years, patient treatment intervals; and adverse events. Results: Of the 36 patients who provided informed consent to participate in the study and were screened, 26 patients (eyes) were eligible to participate in the study. After regression analysis, adjustment for repeated measures, and significant covariates, the mean BCVA increased by 3.8 letters (95% confidence interval [CI] 1.1, 6.4) and the CFT and CSVol decreased by 127.2 lm (95% CI 91.7, 162.5) and 1.6 mm 3 (95% CI 1.2, 2.0), respectively, over the course of the study. In the second year, 16 of the 25 patients still participating had their treatment intervals extended to 12 weeks. There was no evidence of any new adverse events that would require changes to the aflibercept safety profile.
Background: There is no comprehensive study of the costs of horse-related workplace injuries to Australian Thoroughbred racing jockeys. Objectives: To analyse the characteristics of insurance payments and horse-related workplace injuries to Australian jockeys during Thoroughbred racing or training. Methods: Insurance payments to Australian jockeys and apprentice jockeys as a result of claims for injury were reviewed. The cause and nature of injuries, and the breakdown of payments associated with claims were described. Results: The incidence of claims was 2.1/1000 race rides, with an average cost of AUD 9 million/year. Race-day incidents were associated with 39% of claims, but 52% of the total cost. The mean cost of race-day incidents (AUD 33,756) was higher than non-race day incidents (AUD 20,338). Weekly benefits and medical expenses made up the majority of costs of claims. Fractures were the most common injury (29.5%), but head injuries resulting from a fall from a horse had the highest mean cost/claim (AUD 127,127). Conclusions: Costs of workplace injuries to the Australian Thoroughbred racing industry have been greatly underestimated because the focus has historically been on incidents that occur on race-days. These findings add to the evidence base for developing strategies to reduce injuries and their associated costs.
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