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

View Article: PubMed Central - PubMed

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.

Methods/design: 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.

Trial registration: ClinicalTrials.gov: NCT02243878. Registered on 17 September 2014.

No MeSH data available.


Related in: MedlinePlus

a Computer-generated image showing the operator station (left) and SRT machine separated by a lead-lined glass window. b Image showing the suction-coupled contact lens and position of radiotherapy beams passing through inferior sclera to converge on the macula (images courtesy of Oraya)
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Fig2: a Computer-generated image showing the operator station (left) and SRT machine separated by a lead-lined glass window. b Image showing the suction-coupled contact lens and position of radiotherapy beams passing through inferior sclera to converge on the macula (images courtesy of Oraya)

Mentions: SRT will be provided in two or more UK national treatment centres (NTCs). Participants will travel from their recruiting site to the NTC for SRT and then return to their recruiting site for study follow-up. Participants will receive a 16-Gy dose of radiation (or sham treatment) delivered to the macula in a single session using the robotically controlled SRT device, utilising three sequential beams. Each beam deposits 5.3 Gy at the macula, via the pars plana (Fig. 2). If it is not possible to obtain clear access for all three beams, then it may, on occasion, be necessary to deliver radiation through two beams. The dose of radiation will therefore be 8 Gy per beam, identical to the dose delivered in each of the three beams used in the 24 Gy arm of the INTREPID study [16]. Treatment takes about 10–20 minutes.Fig. 2


StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial
a Computer-generated image showing the operator station (left) and SRT machine separated by a lead-lined glass window. b Image showing the suction-coupled contact lens and position of radiotherapy beams passing through inferior sclera to converge on the macula (images courtesy of Oraya)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5121938&req=5

Fig2: a Computer-generated image showing the operator station (left) and SRT machine separated by a lead-lined glass window. b Image showing the suction-coupled contact lens and position of radiotherapy beams passing through inferior sclera to converge on the macula (images courtesy of Oraya)
Mentions: SRT will be provided in two or more UK national treatment centres (NTCs). Participants will travel from their recruiting site to the NTC for SRT and then return to their recruiting site for study follow-up. Participants will receive a 16-Gy dose of radiation (or sham treatment) delivered to the macula in a single session using the robotically controlled SRT device, utilising three sequential beams. Each beam deposits 5.3 Gy at the macula, via the pars plana (Fig. 2). If it is not possible to obtain clear access for all three beams, then it may, on occasion, be necessary to deliver radiation through two beams. The dose of radiation will therefore be 8 Gy per beam, identical to the dose delivered in each of the three beams used in the 24 Gy arm of the INTREPID study [16]. Treatment takes about 10–20 minutes.Fig. 2

View Article: PubMed Central - PubMed

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.

Methods/design: 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.

Trial registration: ClinicalTrials.gov: NCT02243878. Registered on 17 September 2014.

No MeSH data available.


Related in: MedlinePlus