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Predictive imaging biomarkers relevant for functional and anatomical outcomes during ranibizumab therapy of diabetic macular oedema
  1. Bianca S Gerendas1,2,
  2. Sonja Prager1,
  3. Gabor Deak1,
  4. Christian Simader1,
  5. Jan Lammer1,
  6. Sebastian M Waldstein1,2,
  7. Tadhg Guerin3,
  8. Michael Kundi4,
  9. Ursula Margarethe Schmidt-Erfurth1,2
  1. 1 Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria
  2. 2 Christian Doppler Laboratory for Ophthalmic Image Analysis, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria
  3. 3 Novartis Ireland, Dublin, Ireland
  4. 4 Institute of Environmental Health, Center for Public Health, Medical University of Vienna, Vienna, Austria
  1. Correspondence to Professor Ursula Margarethe Schmidt-Erfurth, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria; ursula.schmidt-erfurth{at}meduniwien.ac.at

Abstract

Background/aims The objective is to identify imaging biomarkers in optical coherence tomography predicting functional/anatomical outcomes in diabetic macular oedema (DMO).

Methods The presented study is a post hoc analysis of the RESTORE/RESTORE-extension studies. Best-corrected visual acuity (BCVA) was analysed using general estimating equation models using treatment group/morphological features as predictor variables. In addition, linear multiple regression models analysed BCVA gain up to 12 and 36 months with BCVA/morphological baseline characteristics as independent predictor variables. The correlations between central retinal thickness (CRT)/BCVA were calculated as Spearman’s/Pearson’s correlation coefficients.

Results A weak negative linear correlation between CRT/BCVA was observed in all study arms at baseline (r=−0.34, p<0.001) and at month 36 (r=−0.26, p<0.001). Patients with baseline height of intraretinal cystoid fluid (IRC) ≤380 µm had better baseline BCVA compared with patients with IRC height >380 µm (64.84±10.63 vs 61.66±9.92 letters; p=0.0071, respectively), which was maintained until the end of month 12 (70.5±12.33 vs 67.0±14.09 letters; p=0.0252, respectively). With laser, there was a trend for patients with subretinal fluid (SRF) at baseline to lose BCVA letters at month 12 (−5.38±16.54 vs 2.49±9.72 letters; p=0.1038), whereas ranibizumab patients trended towards higher BCVA gains (10.28±7.14 vs 6.76±7.67; p=0.0563), compared with those without SRF. With combined therapy, all patients had similar BCVA gains regardless of SRF (p=0.3768).

Conclusion With ranibizumab treatment, the height of IRC spaces at baseline was a better predictor of functional/anatomical improvement than CRT alone. There was also a trend for SRF to show a positive impact on ranibizumab therapy response and a negative impact on laser therapy response.

  • imaging
  • macula
  • retina
  • clinical trial

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Footnotes

  • Contributors All authors made substantial contributions to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work; final approval of the version to be published; agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. BSG, SP, TG and UMS-E: drafting the work or revising it critically for important intellectual content.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The institutional review boards or ethics committees at each participating center approved the RESTORE and RESTORE-extension studies; the ethics committee of the Medical University of Vienna approved the post hoc analysis.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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