June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Anatomical outcomes of ranibizumab 0.5 mg combined with verteporfin photodynamic therapy vs ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy: 12-month results from the EVEREST II study
Author Affiliations & Notes
  • Timothy Y Y Lai
    Ophthalmology & Visual Sciences, Chinese University of Hong Kong, Kowloon, Hong Kong
  • Chrystel Feller
    Novartis Pharma AG, Basel, Switzerland
  • Philippe Margaron
    Novartis Pharma AG, Basel, Switzerland
  • Colin S Tan
    National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore, Singapore
    Fundus Image Reading Centre, National Healthcare Group Eye Institute, Singapore, Singapore
  • Footnotes
    Commercial Relationships   Timothy Lai, Allergan (C), Bayer (C), Genentech (C), Novartis (C); Chrystel Feller, Novartis (E); Philippe Margaron, Novartis (E); Colin Tan, Bayer (R), Heidelberg Engineering (R), Novartis (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 408. doi:
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    • Get Citation

      Timothy Y Y Lai, Chrystel Feller, Philippe Margaron, Colin S Tan; Anatomical outcomes of ranibizumab 0.5 mg combined with verteporfin photodynamic therapy vs ranibizumab monotherapy in patients with polypoidal choroidal vasculopathy: 12-month results from the EVEREST II study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):408.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To report 12-month (M) anatomical outcomes of the EVEREST II study (NCT01846273), which compared ranibizumab 0.5 mg (RBZ) + verteporfin photodynamic therapy (vPDT) vs RBZ monotherapy in Asian patients with symptomatic macular polypoidal choroidal vasculopathy (PCV).

Methods : This 24M, phase IV, double-masked, multicenter study included 322 PCV eyes with active polyps that were randomized 1:1 to receive RBZ + vPDT (n=168) or RBZ monotherapy (n=154). Study eye eligibility was confirmed by indocyanine green angiography (ICGA) and color fundus photography using specified diagnostic criteria. Central subfield thickness (CSFT), presence of intra- or subretinal fluid (SRF), and central choroidal thickness (CCT) were assessed on spectral domain optical coherence tomography (SD-OCT) by the central reading center at baseline, M3, M6, and M12. Disease activity was defined as either best-corrected visual acuity (BCVA) loss or OCT abnormality reported by the investigators.

Results : Baseline OCT characteristics were well balanced between treatment arms. The RBZ + vPDT arm showed greater mean CSFT reduction at M12 than the RBZ arm (−163.8 μm vs −114.6 μm, p<0.001; Fig. 1A). At M12, 83.2% and 60.3% patients in the RBZ + vPDT and RBZ arms, respectively, had CSFT <300 μm. Mean CCT change from baseline to M12 was higher in the RBZ + vPDT arm than the RBZ arm (−55.2 μm vs −30.1 μm; Fig. 1B). A smaller proportion of patients in the RBZ + vPDT arm had disease activity from M3 to M11 vs the RBZ arm (M3, 26.4% vs 60.7%; M11, 20.5% vs 50.0%). At M3 and M12, 62.0% and 56.8% patients in the RBZ + vPDT arm and 37.1% and 28.7% in the RBZ arm had fluid-free retina, respectively (Fig. 2A). The proportion of patients with SRF present at baseline, but absent at M3 and M12, was higher with RBZ + vPDT than RBZ monotherapy (M3, 73.0% vs 44.1%; M12, 69.8% vs 39.7%; Fig. 2B).

Conclusions : These findings are consistent with the primary outcomes of EVEREST II which confirmed that both RBZ and RBZ in combination with vPDT are effective treatment options for patients with PCV. RBZ in combination with vPDT resulted in additional BCVA improvement and higher polyp regression as well as had more marked anatomical benefits over RBZ monotherapy.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

 

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