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StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial.

ABSTRACT: BACKGROUND:The standard of care for neovascular age-related macular degeneration (nAMD) involves ongoing intravitreal injections of anti-angiogenic drugs targeting vascular endothelial growth factor (VEGF). The most commonly used anti-VEGF drugs are ranibizumab, bevacizumab and aflibercept. The main objective of the STAR trial is to determine if stereotactic radiotherapy can reduce the number of anti-VEGF injections that patients with nAMD require. METHODS/DESIGN:STAR is a multicentre, double-masked, randomised, sham-controlled clinical trial. It evaluates a new device (manufactured by Oraya, Newark, CA, USA) designed to deliver stereotactic radiotherapy (SRT) to nAMD lesions. The trial enrols participants with chronic, active nAMD. Participants receive a single SRT treatment (16 Gy or sham) with a concomitant baseline intravitreal injection of 0.5 mg ranibizumab. Thereafter, they attend every month for 24 months, and ranibizumab is administered at the visit if retreatment criteria are met. The primary outcome is the number of pro re nata ranibizumab injections during the first 24 months. Secondary outcomes include visual acuity, lesion morphology, quality of life and safety. Additional visits occur at 36 and 48 months to inspect for radiation retinopathy. The target sample size of 411 participants (randomised 2:1 in favour of radiation) is designed to detect a reduction of 2.5 injections against ranibizumab monotherapy, at 90% power, and a significance level (alpha) of 0.025 (one-sided two-sample t test). This gives 97% power to detect non-inferiority of visual acuity at a five-letter margin. The primary analyses will be by intention to treat. DISCUSSION:The safety and efficacy outcomes will help determine the role of SRT in the management of chronic, active nAMD. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number: ISRCTN12884465. Registered on 28 November 2014. ClinicalTrials.gov: NCT02243878 . Registered on 17 September 2014.

SUBMITTER: Neffendorf JE

PROVIDER: S-EPMC5121938 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial.

Neffendorf James E JE Desai Riti R Wang Yanzhong Y Kelly Joanna J Murphy Caroline C Reeves Barnaby C BC Chakravarthy Usha U Wordsworth Sarah S Lewis Cornelius C Peacock Janet J Uddin Shahir S O'Sullivan Joe M JM Jackson Timothy L TL

Trials 20161124 1

<h4>Background</h4>The standard of care for neovascular age-related macular degeneration (nAMD) involves ongoing intravitreal injections of anti-angiogenic drugs targeting vascular endothelial growth factor (VEGF). The most commonly used anti-VEGF drugs are ranibizumab, bevacizumab and aflibercept. The main objective of the STAR trial is to determine if stereotactic radiotherapy can reduce the number of anti-VEGF injections that patients with nAMD require.<h4>Methods/design</h4>STAR is a multice ...[more]

PMID: 27881184

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Project description:IntroductionAge-related macular degeneration (AMD) is a leading cause of blindness. After smoking, nutrition is the key modifiable factor in reducing AMD incidence and progression, and no other preventative treatments are currently available. At present, there is an evidence-practice gap of dietary recommendations made by eye care practitioners and those actually practised by patients with AMD. To address this gap, a telephone-delivered dietary intervention tailored to patients with AMD will be piloted. The study aims to improve dietary intake and behaviours in patients with AMD. This type of nutrition-focused healthcare is currently not considered in the long-term management of AMD and represents the first empirical evaluation of a telephone-supported application encouraging adherence to dietary recommendations for AMD.Methods and analysis140 participants with AMD will be recruited for this randomised controlled trial. Those lacking English fluency; unwilling to engage in the intervention or provide informed consent were excluded. Following the completion of the baseline questionnaire, participants will be randomised into one of two arms: intervention or wait-list control (70 each in the intervention and control groups). Intervention participants will receive a detailed mail-delivered workbook containing information on healthy eating behaviours that promote optimal macular health, as well as scheduled phone calls over 4 months from an accredited practising dietitian. Descriptive statistics and multivariate stepwise linear regressions analyses will be used to summarise and determine the changes in dietary intakes, respectively. Economic analysis will be conducted to determine intervention feasibility and possibility of a large-scale rollout.Ethics and disseminationThe study was approved by the University of Sydney Human Research Ethics Committee (HREC) (Reference: HREC 2018/219). Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journal articles.Trial registration numberACTRN12618000527268; Pre-results.

Dataset Information

StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial.

Publications

StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial.

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