Background: Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness. The first-line therapy is anti-vascular endothelial growth factor (anti-VEGF) agents delivered by intravitreal injection. Ionising radiation mitigates key pathogenic processes underlying nAMD, and therefore has therapeutic potential. STAR aimed to assess whether stereotactic radiotherapy (SRT) reduces the number of anti-VEGF injections required, without sacrificing visual acuity.
Methods: This pivotal, randomised, double-masked, sham-controlled trial enrolled participants with pretreated chronic active nAMD from 30 UK hospitals. Participants were randomly allocated in a 2:1 ratio to 16-Gray (Gy) SRT delivered using a robotically controlled device or sham SRT, stratified by treatment centre. Eligible participants were aged 50 years or older and had chronic active nAMD, with at least three previous anti-VEGF injections, including at least one in the last 4 months. Participants and all trial and image reading centre staff were masked to treatment allocation, except one unmasked statistician. The primary outcome was the number of intravitreal ranibizumab injections required over 2 years, tested for superiority (fewer injections). The main secondary outcome was Early Treatment Diabetic Retinopathy Study visual acuity at two years, tested for non-inferiority (five-letter margin). The primary analysis used the intention-to-treat principle, and safety was analysed per-protocol on participants with available data. The study is registered with ClinicalTrials.gov (NCT02243878) and is closed for recruitment.
Findings: 411 participants enrolled between Jan 1, 2015, and Dec 27, 2019, and 274 were randomly allocated to the 16-Gy SRT group and 137 to the sham SRT group. 240 (58%) of all participants were female, and 171 (42%) of all participants were male. 241 participants in the 16-Gy SRT group and 118 participants in the sham group were included in the final analysis, and 409 patients were treated and formed the safety population, of whom two patients allocated to sham treatment erroneously received 16-Gy SRT. The SRT group received a mean of 10·7 injections (SD 6·3) over 2 years versus 13·3 injections (5·8) with sham, a reduction of 2·9 injections after adjusting for treatment centre (95% CI -4·2 to -1·6, p<0·0001). The SRT group best-corrected visual acuity change was non-inferior to sham (adjusted mean letter loss difference between groups, -1·7 letters [95% CI -4·2 to 0·8]). Adverse event rates were similar across groups, but reading centre-detected microvascular abnormalities occurred in 77 SRT-treated eyes (35%) and 13 (12%) sham-treated eyes. Overall, eyes with microvascular abnormalities tended to have better best-corrected visual acuity than those without. Fewer ranibizumab injections offset the cost of SRT, saving a mean of £565 per participant (95% CI -332 to 1483).
Interpretation: SRT can reduce ranibizumab treatment burden without compromising vision.
Funding: Medical Research Council and National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme.
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http://dx.doi.org/10.1016/S0140-6736(24)00687-1 | DOI Listing |
Health Serv Insights
December 2024
Department of Gynecology and Obstetrics, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Objectives: Residency training is important worldwide and recent studies have put more emphasis on its quality evaluation. This study aims to first explore the impact of educational backgrounds on the quality of gynecology and obstetrics (OB-GYN) standardized resident training (SRT) program in China, which may provide crucial evidence for policy considerations to improve SRT quality.
Methods: A total of 397 OB-GYN resident graduates were enrolled in this retrospective cohort study.
Front Hum Neurosci
November 2024
School of Mental Health, Bengbu Medical University, Bengbu, China.
Background: Temporal interference electrical stimulation (TI) is promise in targeting deep brain regions focally. However, limited electric field intensity challenges its efficacy.
Objective: This study aimed to introduce a high-current TI electrical stimulation protocol to enhance its intensity and evaluate its safety and efficacy when applied to the primary motor cortex (M1) in the human brain.
Int J Pediatr Otorhinolaryngol
December 2024
Department of Otolaryngology- Head and Neck Surgery, Emory University School of Medicine, Atlanta, GA, USA; Division of Otolaryngology, Children's Healthcare of Atlanta, Atlanta, GA, USA.
Objective: To present our experience with off-label MED-EL Bonebridge implantation in pediatric patients younger than 12 years of age and compare outcomes to pediatric patients 12 years and older.
Methods: Pediatric patients who underwent Bonebridge implantation were included in a retrospective cohort study and were categorized by off-label use (<12 years) and ≥12 years at time of bone conduction implantation (BCI). Hearing outcomes were collected after implant activation, which was typically 4-8 weeks post-implantation.
J Bodyw Mov Ther
March 2025
Division of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Halic University, Istanbul, Turkey; Department of Physical Therapy and Rehabilitation, Institute of Health Sciences, İstanbul Medipol University, Istanbul, Turkey. Electronic address:
Background: Myofascial release technique (MFR) is frequently used in the treatment of patients with chronic low back pain (CLBP), but there are limited studies on the acute effects of this technique. It was aimed to determine the acute effect of MFR technique on pain and flexibility in CLBP.
Methods: Forty CLBP patients (19 female; 21 male) with an average age of 40 years were randomized as MFR technique and classical massage groups.
Clin Oncol (R Coll Radiol)
November 2024
Hall-Edwards Radiotherapy Research Group, Cancer Centre, Queen Elizabeth Hospital, Birmingham, UK.
Aims: Treatment with stereotactic radiosurgery/radiotherapy (SRS/SRT) is standard practice in selected patients with small numbers of brain metastases (BMs). It is less accepted in those with ≥5 BMs, due to the lack of a prospective evidence base. While randomised trials are ongoing, we present the experience of a single UK cancer centre in using SRS/SRT for patients with 5 or more BMs without whole brain radiotherapy (WBRT).
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