Stereotactic Radiotherapy for Wet Age-Related Macular Degeneration (Intrepid)

Jackson, Timothy L.; Shusterman, E. Mark; Arnoldussen, Mark; Chell, E; Wang, Kun; Moshfeghi, Darius M.

doi:10.1097/iae.0000000000000283

Cited by 20 publications

(25 citation statements)

References 22 publications

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“…Mikrovaskulä-re Anomalien, die möglicherweise radiogen waren, wurden in 1 % der Fälle angegeben und waren im Beobachtungszeitraum nicht visusrelevant. Eine post-hoc durchgeführte Subgruppenanalyse konnte darüber hinaus zeigen, dass Läsionen unter 4 mm Querschnitt und mit einem Volumen über 7,4 mm 3 deutlich besser auf die adjuvante stereotaktische Therapie ansprachen als die gesamte Kohorte [22].…”

Section: Mikrokollimierte 100 Kv Strahlentherapie (Iray-system)unclassified

Stellungnahme der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands zur Strahlentherapie bei neovaskulärer altersabhängiger Makuladegeneration

Gesellschaft

Gesellschaft²,

Deutschlands

2015

Ophthalmologe

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Section: Mikrokollimierte 100 Kv Strahlentherapie (Iray-system)unclassified

Stellungnahme der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands zur Strahlentherapie bei neovaskulärer altersabhängiger Makuladegeneration

Gesellschaft

Gesellschaft²,

Deutschlands

2015

Ophthalmologe

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“…Responder analysis indicates that choroidal neovascularisation (CNV) lesion size ≤4 mm in greatest linear diameter (GLD), abnormal macular volume and limited fibrosis are positive response predictors. 16 A closer look at the data also shows that time since diagnosis or number of previous injections are not correlated with outcomes, leading to the conclusion that morphological parameters should be used exclusively to determine if a patient is a good candidate for SRT.…”

Section: Opinionmentioning

confidence: 99%

“…15 The study examined the effect of SRT adjunctive to anti-VEGF therapy versus sham SRT and anti-VEGF mono-therapy at year 1. 16 The beneficial effect was maintained through year 2, although slightly reduced. 17 Recently, an intraocular β-radiation delivery system was developed to treat wet AMD using an epimacular brachytherapy (EMBT) technique.…”

mentioning

confidence: 96%

Low-energy Stereotactic Radiotherapy for Treatment of Exudative Age-related Macular Degeneration Adjunctive to Anti-VEGF Therapy

Hatz¹,

Zimmermann²,

Kardamakis³

et al. 2015

European Ophthalmic Review

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The number of cases of patients with exudative age-related macular degeneration (wet AMD) is increasing, partly due to an ageing population and lifestyle risk factors, such as smoking. The treatment of wet AMD has been revolutionised by the advent of anti-vascular endothelial growth factor (anti-VEGF) agents, though it is an important aim to reduce the treatment burden for patients with the need for highly frequent treatment. Previously, combinations of anti-VEGF with Verteporfin PhotoDynamic Therapy and radiation therapy were used to achieve this aim. More recently, stereotactic radiotherapy (SRT) has been shown in the IRay Plus Anti-VEGF Treatment For Patients With Wet AMD (INTREPID) study to preserve vision while sparing injections of anti-VEGF. Using a highly collimated, narrow X-ray beam, the dose of radiation is delivered in three closely spaced applications within a single session through different entry points in the inferior pars plana of the affected eye. The total application time is usually less than 60 minutes. Centred on the fovea, the sequential beams converge on the retina to deliver a 16 Gy dose to an area of 4 mm in diameter. In this opinion-based article, the practical application of SRT adjunctive to anti-VEGF therapy is discussed and illustrated with a series of case studies. KeywordsStereotactic radiotherapy (SRT),radiosurgery (SRS), radiotherapy, ionising radiation, neovascular age-related macular degeneration (wet AMD), anti-vascular endothelial growth factor (anti-VEGF) Disclosure: Katja Hatz has received fees for lectures and congress travel expenses from Alcon, Allergan, Bayer Switzerland, Novartis, Oraya and Roche and advisory board fees from

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“…In terms of safety, SRT was shown to induce microvascular abnormalities, but in only 1% of eyes was vision possibly affected at the 2-year follow-up. A subgroup analysis showed the best responders were those where the AMD lesion had a greatest linear dimension <4 mm (corresponding to the 90% isodose size) and when the lesion was actively leaking at the time of SRT [18]. …”

Section: Introductionmentioning

confidence: 99%

“…The STAR trial is a phase III study that builds on the phase II INTREPID study, targeting patients with chronic active nAMD, but it selectively recruits those thought most responsive to SRT, namely those with active leakage at enrolment and with lesions <4 mm [18]. It aims to determine if SRT with prn ranibizumab is a safe and effective treatment compared to prn ranibizumab monotherapy.…”

Section: Introductionmentioning

confidence: 99%

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

Neffendorf

Desai

Wang

et al. 2016

Trials

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BackgroundThe 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/designSTAR 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.DiscussionThe safety and efficacy outcomes will help determine the role of SRT in the management of chronic, active nAMD.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN12884465. Registered on 28 November 2014. ClinicalTrials.gov: NCT02243878. Registered on 17 September 2014.

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Stereotactic Radiotherapy for Wet Age-Related Macular Degeneration (Intrepid)

Cited by 20 publications

References 22 publications

Stellungnahme der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands zur Strahlentherapie bei neovaskulärer altersabhängiger Makuladegeneration

Stellungnahme der Retinologischen Gesellschaft, der Deutschen Ophthalmologischen Gesellschaft und des Berufsverbands der Augenärzte Deutschlands zur Strahlentherapie bei neovaskulärer altersabhängiger Makuladegeneration

Low-energy Stereotactic Radiotherapy for Treatment of Exudative Age-related Macular Degeneration Adjunctive to Anti-VEGF Therapy

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

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