Potential selection bias in candidates for stereotactic radiotherapy for neovascular AMD

Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):105-111. doi: 10.1007/s00417-017-3849-9. Epub 2017 Nov 22.

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.

Keywords: AMD; Cross-sectional study; Eligibility; Stereotactic radiotherapy.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Aged, 80 and over
  • Cross-Sectional Studies
  • Female
  • Follow-Up Studies
  • Germany / epidemiology
  • Humans
  • Male
  • Patient Selection*
  • Prevalence
  • Radiosurgery / methods*
  • Retrospective Studies
  • Selection Bias
  • Tomography, Optical Coherence
  • Wet Macular Degeneration / drug therapy
  • Wet Macular Degeneration / epidemiology*
  • Wet Macular Degeneration / radiotherapy*