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

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ID: 80790
2016
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Abstract
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.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.The safety and efficacy outcomes will help determine the role of SRT in the management of chronic, active nAMD.International Standard Randomised Controlled Trial Number: ISRCTN12884465. Registered on 28 November 2014. ClinicalTrials.gov: NCT02243878 . Registered on 17 September 2014.
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neffendorf2016stereotactictrials Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Neffendorf, James E;Desai, Riti;Wang, Yanzhong;Kelly, Joanna;Murphy, Caroline;Reeves, Barnaby C;Chakravarthy, Usha;Wordsworth, Sarah;Lewis, Cornelius;Peacock, Janet;Uddin, Shahir;O'Sullivan, Joe M;Jackson, Timothy L;
Journal Trials
Year 2016
DOI
DOI not found
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Keywords
radiation vegf stereotactic radiotherapy neovascular age-related macular degeneration anti-vascular endothelial growth factor ranibizumab star study wet age-related macular degeneration

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