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Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: The EVEREST II Randomized Clinical Trial

Lim TH 1 , Lai TYY 2 , Takahashi K 3 , Wong TY 4 , Chen LJ 5 , Ruamviboonsuk P 6 Show all authors , Tan CS 1 , Lee WK 7 , Cheung CMG 4 , Ngah NF 8 , Patalauskaite R 9 , Margaron P 10 , Koh A 11 , EVEREST II Study Group

Affiliations 

  • 1 National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore
  • 2 Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China
  • 3 Department of Ophthalmology, Kansai Medical University, Osaka, Japan
  • 4 Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, National University of Singapore, Singapore
  • 5 Department of Ophthalmology, Mackay Memorial Hospital, Taipei, Taiwan
  • 6 Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand
  • 7 Department of Ophthalmology, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea
  • 8 Department of Ophthalmology, Hospital Shah Alam, Malaysia
  • 9 Novartis Ireland Ltd, Dublin, Ireland
  • 10 Novartis Pharma AG, Basel, Switzerland
  • 11 Eye & Retina Surgeons, Camden Medical Centre, Singapore
JAMA Ophthalmol, 2020 09 01;138(9):935-942.
PMID: 32672800 DOI: 10.1001/jamaophthalmol.2020.2443

Abstract

Importance: The 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear.

Objective: To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months.

Design, Setting, and Participants: This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography.

Interventions: Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions.

Main Outcomes and Measures: Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions.

Results: Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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