June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Evaluation of polypoidal choroidal vasculopathy lesions on indocyanine green angiograms in the first year of the EVEREST II study
Author Affiliations & Notes
  • Colin S Tan
    Ophthalmology, National Healthcare Group Eye Institute, Singapore, Singapore
  • Chrystel Feller
    Novartis Pharma AG, Basel, Switzerland
  • Philippe Margaron
    Novartis Pharma AG, Basel, Switzerland
  • Tock H Lim
    Ophthalmology, National Healthcare Group Eye Institute, Singapore, Singapore
  • Footnotes
    Commercial Relationships   Colin Tan, Bayer (R), Heidelberg Engineering (R), Novartis (R); Chrystel Feller, Novartis (E); Philippe Margaron, Novartis (E); Tock Lim, Heidelberg Engineering (R), Novartis (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 906. doi:
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      Colin S Tan, Chrystel Feller, Philippe Margaron, Tock H Lim; Evaluation of polypoidal choroidal vasculopathy lesions on indocyanine green angiograms in the first year of the EVEREST II study
      . Invest. Ophthalmol. Vis. Sci. 2017;58(8):906.

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

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Abstract

Purpose : To report polyps and branching vascular network (BVN) responses to ranibizumab 0.5 mg (RBZ) + verteporfin photodynamic therapy (vPDT) vs RBZ monotherapy on indocyanine green angiograms (ICGA) within the first 12 months of the EVEREST II (NCT01846273) study.

Methods : This 24-month, phase IV, double-masked, multicenter study included 322 eyes from Asian patients with symptomatic macular polypoidal choroidal vasculopathy (PCV) who were randomized 1:1 to receive RBZ + vPDT (n = 168) or RBZ monotherapy (n = 154). Study eye eligibility was confirmed by the central reading center (FIRC) using ICGA and color fundus photography using specified diagnostic criteria. Presence and size of polyps and BVN were assessed on ICGA by the reading center at baseline, Month (M) 3, M6, and M12.

Results : Baseline ICGA characteristics were well-balanced between both treatment arms. Complete polyp regression was found in 71.4% of patients treated with RBZ + vPDT at M3 and was thereafter stable (71.3% at M6 and 69.7% at M12), whereas it increased from 23.3% at M3 to 28.0% at M6 and 33.8% at M12 for RBZ monotherapy. The area of polyps still active at M3 decreased on average (± SD) by 0.257 ± 0.267 mm2 from baseline in the RBZ + vPDT arm vs 0.132 ± 0.287 mm2 in the RBZ monotherapy arm; at M12, the reductions in polyp area from baseline were 0.243 ± 0.350 mm2 and 0.112 ± 0.230 mm2, respectively. BVN was present in 94.4% of patients at baseline. Among this BVN cohort, BVN was not detected in 22.2% at M3, 15.3% at M6, and 6.0% at M12 in the combination arm vs 4.3%, 7.1%, and 4.5% for RBZ monotherapy, respectively. In RBZ + vPDT patients with open BVN, BVN area initially increased from a mean (± SD) of 3.270 ± 2.725 mm2 at baseline to 3.421 ± 2.714 mm2 at M6, compared to a more marked increase from 2.640 ± 2.246 mm2 at baseline to 3.128 ± 2.619 mm2 at M6 for RBZ monotherapy. However, the overall increase in BVN area from baseline at M12 was comparable between both arms (0.622 ± 1.846 mm2 for RBZ + vPDT vs 0.736 ± 1.628 mm2 for RBZ monotherapy).

Conclusions : Whereas the combination of prompt RBZ + vPDT therapy moderately and transiently impacted BVN closure and area in PCV patients, combination therapy evoked at least twice as much complete polyp regression and a larger reduction in polyp area than RBZ alone.

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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