16-Gy Low-Voltage X-ray Irradiation With Ranibizumab Therapy for AMD: 6-Month Safety and Functional Outcomes

Cantón, Virgilio Morales; Quiroz‐Mercado, Hugo; Vélez-Montoya, Raúl; Lopez-Miranda, M. J.; Moshfeghi, Andrew A; Shusterman, E. Mark; Kaiser, Peter K.; Sanislo, Steven R.; Gertner, Michael; Moshfeghi, Darius M.

doi:10.3928/15428877-20110804-01

Cited by 17 publications

(11 citation statements)

References 38 publications

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“…At 6-month follow-up, the 16-and 24-Gy doses, in conjunction with baseline loading of ranibizumab, resulted in improvement in visual acuity with a decreased need for injections [59,70,79]. There were no incidences of cataract progression, radiation retinopathy, and optic neuropathy in any group [59,70,79]. At 6 months, the mean change in visual acuity was ?6.4 ± 9.8 ETDRS letters.…”

Section: Low-voltage Stereotactic Radiotherapy (Srt) In Amdmentioning

confidence: 88%

“…Actual dose over the entire macula is calculated from analysis of the ocular movements during the treatment session. Radiation therapy consists of a fraction of 16 or 24 Gy delivered in approximately 15 min (about 3-5 min of X-ray exposure) over 3 equal spots in the inferior pars plana [59,70,71]. An active suction apparatus along with infrared markers tracks the eye in the X, Y, and Z planes or rotational angles.…”

Section: Low-voltage Stereotactic Radiotherapy (Srt) In Amdmentioning

confidence: 99%

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Brachytherapy in Neovascular AMD

Grewal

Vajzovic

2015

Curr Ophthalmol Rep

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Neovascular age-related macular degeneration (AMD) has a complex pathophysiology, and although anti-VEGF therapy has been one of the most significant and successful advances, it is not effective for all patients with neovascular AMD. The potential role of radiation in the management of neovascular AMD has been suggested for several years. While previous work focused on the role of radiation alone, recent trials have evaluated the role of ionizing radiation as a synergistic treatment with anti-VEGF drugs, with endpoints being to reduce choroidal neovascular lesions faster, preserve visual acuity, and extend the treatment interval between injections. We review the current evidence available for the safety and efficacy of radiation in conjunction with anti-VEGF treatment for neovascular AMD delivered using three approaches-epimacular brachytherapy involving a pars plana vitrectomy (Vidion Neovista, Inc., Newark, CA, USA), episcleral brachytherapy without a pars plana vitrectomy (Salutaris Medical Devices, Tucson, AZ), and low-voltage stereotactic radiotherapy (IRay,

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Section: Low-voltage Stereotactic Radiotherapy (Srt) In Amdmentioning

confidence: 88%

Section: Low-voltage Stereotactic Radiotherapy (Srt) In Amdmentioning

confidence: 99%

Brachytherapy in Neovascular AMD

Grewal

Vajzovic

2015

Curr Ophthalmol Rep

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“…The Oraya Therapy system can accurately deliver a radiation dose of up to 24 Gy to the radiosensitive choroidal neovasculature during a single treatment session, while maintaining dose limits to neighboring organs at risk [145,149]. A novel multimodality approach comprising Oraya Therapy of 16 or 24 Gy, and concomitant treatment with a VEGF inhibitor has also been developed [150] and implemented in clinical trials with no radiation-related adverse effects at 6 months [151–153]. …”

Section: Emerging Gnrt Modalitiesmentioning

confidence: 99%

Targeted Radiotherapy with Gold Nanoparticles: Current Status and Future Perspectives

et al. 2014

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Radiation therapy (RT) is the treatment of cancer and other diseases with ionizing radiation. The ultimate goal of RT is to destroy all the disease cells while sparing healthy tissue. Towards this goal, RT has advanced significantly over the past few decades in part due to new technologies including: multileaf collimator-assisted modulation of radiation beams, improved computer-assisted inverse treatment planning, image guidance, robotics with more precision, better motion management strategies, stereotactic treatments and hypofractionation. With recent advances in nanotechnology, targeted RT with gold nanoparticles (GNPs) is actively being investigated as a means to further increase the RT therapeutic ratio. In this review, we summarize the current status of research and development towards the use of GNPs to enhance RT. We highlight the promising emerging modalities for targeted RT with GNPs and the corresponding preclinical evidence supporting such promise towards potential clinical translation. Future prospects and perspectives are discussed.

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“…The StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR) trial investigates a new CE marked device, manufactured by Oraya (Newark, CA, USA), that uses radiation to treat nAMD, in a process called stereotactic radiotherapy (SRT) [9–11]. Oraya’s SRT system is an outpatient-based radiotherapy platform that provides stereotactic application of low-energy X-ray radiation to the retina [12–14].…”

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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16-Gy Low-Voltage X-ray Irradiation With Ranibizumab Therapy for AMD: 6-Month Safety and Functional Outcomes

Abstract: A single treatment of externally applied, non-invasive 16-Gy low-voltage x-ray therapy in conjunction with ranibizumab demonstrated an overall improvement of VA in patients with neovascular AMD at 6 months with no radiation-related adverse effects.

Cited by 17 publications

References 38 publications

Brachytherapy in Neovascular AMD

Brachytherapy in Neovascular AMD

Targeted Radiotherapy with Gold Nanoparticles: Current Status and Future Perspectives

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

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