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EVEREST STUDY: Efficacy and Safety of Verteporfin Photodynamic Therapy in Combination with Ranibizumab or Alone Versus Ranibizumab Monotherapy in Patients with Symptomatic Macular Polypoidal Choroidal Vasculopathy

Koh, Adrian MD, FRCS*; Lee, Won Ki MD, PhD; Chen, Lee-Jen MD; Chen, Shih-Jen MD, PhD§,¶; Hashad, Yehia MD**; Kim, Hakyoung MD, PhD††; Lai, Timothy Y. MD, FRCS‡‡; Pilz, Stefan PhD§§; Ruamviboonsuk, Paisan MD¶¶; Tokaji, Erika PhD§§; Weisberger, Annemarie MD***; Lim, Tock H. FRCS(Ed)†††

doi: 10.1097/IAE.0b013e31824f91e8
Original Study

Purpose: To assess the effects of verteporfin photodynamic therapy (PDT) combined with ranibizumab or alone versus ranibizumab monotherapy in patients with symptomatic macular polypoidal choroidal vasculopathy.

Methods: In this multicenter, double-masked, primarily indocyanine green angiography–guided trial, 61 Asian patients were randomized to verteporfin PDT (standard fluence), ranibizumab 0.5 mg, or the combination. Patients were administered with verteporfin PDT/placebo and initiated with three consecutive monthly ranibizumab/sham injections starting Day 1, and re-treated (Months 3–5) as per predefined criteria. The primary endpoint was the proportion of patients with indocyanine green angiography–assessed complete regression of polyps at Month 6. Secondary endpoints included mean change in best-corrected visual acuity at Month 6 and safety.

Results: At Month 6, verteporfin combined with ranibizumab or alone was superior to ranibizumab monotherapy in achieving complete polyp regression (77.8% and 71.4% vs. 28.6%; P < 0.01); mean change ± standard deviation in best-corrected visual acuity (letters) was 10.9 ± 10.9 (verteporfin PDT + ranibizumab), 7.5 ± 10.6 (verteporfin PDT), and 9.2 ± 12.4 (ranibizumab). There were no new safety findings with either drug used alone or in combination.

Conclusion: Verteporfin PDT combined with ranibizumab 0.5 mg or alone was superior to ranibizumab monotherapy in achieving complete regression of polyps in this 6-month study in patients with symptomatic macular polypoidal choroidal vasculopathy. All treatments were well tolerated over 6 months.

Supplemental Digital Content is Available in the Text.EVEREST, the first, multicenter, double-masked, primarily indocyanine green angiography–guided randomized controlled trial for symptomatic macular polypoidal choroidal vasculopathy, demonstrated superiority of verteporfin photodynamic therapy combined with ranibizumab or alone over ranibizumab monotherapy in achieving complete regression of polyps at Month 6. Best-corrected visual acuity improved in all treatment arms.

*Eye & Retina Surgeons Clinic, Camden Medical Centre, Singapore, Singapore

Department of Ophthalmology, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea

Department of Ophthalmology, Mackay Memorial Hospital, Taipei, Taiwan

§Department of Ophthalmology, Taipei Veterans General Hospital, Taipei, Taiwan

School of Medicine, National Yang-Ming University, Taipei, Taiwan

**Clinical Research and Development, Retina, Allergan, Inc., Irvine, California

††Department of Ophthalmology, Kangnam Sacred Heart Hospital, Hallym University, Seoul, Korea

‡‡Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong, China

§§Novartis Pharma AG, Basel, Switzerland

¶¶Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand

***Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

†††National Healthcare Group Eye Institute, Tan Tock Seng Hospital, Singapore, Singapore.

Reprint requests: Won Ki Lee, MD, PhD, Department of Ophthalmology, Seoul St Mary's Hospital, The Catholic University of Korea, 505 Banpo-Dong, Seocho-Gu, Seoul 137-701, Korea; e-mail: wklee@catholic.ac.kr

Supported by Novartis Pharma AG, Basel, Switzerland.

EVEREST study is registered at clinicaltrials.gov as NCT00674323. The results have been presented at APVRS 2009, Taipei, Taiwan, and at ARVO Annual meeting 2010, Fort Lauderdale, Florida.

Dr. T. Y. Lai has received honoraria for lecture fees and serving as a consultant for Novartis Pharmaceutical Inc. S. Pilz and E. Tokaji are employees of Novartis Pharma AG, Basel, Switzerland. A. Weisberger is an employee of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.retinajournal.com).

© The Ophthalmic Communications Society, Inc.