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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: James E. Neffendorf, Riti Desai, Yanzhong Wang, Joanna Kelly, Caroline Murphy, Barnaby C. Reeves, Usha Chakravarthy, Sarah Wordsworth, Cornelius Lewis, Janet Peacock, Shahir Uddin, Joe M. O’Sullivan, Timothy L. Jackson

Published in: Trials | Issue 1/2016

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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.
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Metadata
Title
StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial
Authors
James E. Neffendorf
Riti Desai
Yanzhong Wang
Joanna Kelly
Caroline Murphy
Barnaby C. Reeves
Usha Chakravarthy
Sarah Wordsworth
Cornelius Lewis
Janet Peacock
Shahir Uddin
Joe M. O’Sullivan
Timothy L. Jackson
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1676-7

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