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Potential selection bias in candidates for stereotactic radiotherapy for neovascular AMD

  • Retinal Disorders
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

Stereotactic radiotherapy (SRT, IRay) was able to reduce the need for intravitreal injections of anti-VEGF (IVI) in patients with neovascular AMD (nAMD) in a phase II randomized clinical trial. Certain morphologic characteristics, such as lesion size < 4 mm2 or lack of fibrosis, were associated with a better response. The purpose of this cross-sectional study was to investigate eligibility for SRT in a clinical routine setting and to compare clinical features of eligible and non-eligible patients.

Methods

Cross-sectional study of 468 patients treated for nAMD in one study center within a period of 4 months. Clinical features, such as visual acuity or number of IVI since diagnosis and within 6/12 months, as well as the presence for exclusion criteria for SRT were analyzed. Exclusion criteria were sub-divided into lesion-associated (relevant fibrosis, lesion size > 4 mm2, PE tear), ocular comorbidity (e.g., macular comorbidity, vascular disease) and systemic comorbidity (e.g., dementia or tremor).

Results

Exclusion criteria were met by 255 patients (54.5%). Exclusion was most dominantly associated with lesion-associated criteria (80.0%) and less often with ocular (20.8%) or systemic (9.4%) comorbidity. A total of 213 patients (45.5%) fulfilled eligibility criteria. Eligible patients had a better VA at time of analysis (0.36 vs. 0.56 logMAR, p < 0.0001) and at baseline (0.38 vs. 0.56 logMAR, p < 0.0001) compared to non-eligible patients. The numbers of previous intravitreal injections since diagnosis in strictly PRN-treated patients served as a surrogate marker for lesion activity and was comparable within the last 6/12 months. Non-eligible patients had a higher number of different anti-VEGF drugs (1.8 vs. 1.6, p = 0.038).

Conclusions

SRT in addition to anti-VEGF can be an option in every second patient with nAMD. Due to morphological exclusion criteria, patients eligible for SRT had a better VA and a better clinical response compared to non-eligible patients.

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Funding

No funding was received for this research.

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Authors and Affiliations

  1. Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany

    Christoph Ehlken, Daniel Böhringer, Hansjürgen T. Agostini, Bastian Grundel & Milena Stech

  2. Department of Ophthalmology, University Hospital Schleswig-Holstein, Kiel, Germany

    Christoph Ehlken

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  1. Christoph Ehlken
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  2. Daniel Böhringer
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  3. Hansjürgen T. Agostini
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  4. Bastian Grundel
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  5. Milena Stech
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Correspondence to Christoph Ehlken.

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All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee (place name of institute/committee) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Ehlken, C., Böhringer, D., Agostini, H.T. et al. Potential selection bias in candidates for stereotactic radiotherapy for neovascular AMD. Graefes Arch Clin Exp Ophthalmol 256, 105–111 (2018). https://doi.org/10.1007/s00417-017-3849-9

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  • DOI: https://doi.org/10.1007/s00417-017-3849-9

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