June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and Safety of Intravitreal Aflibercept in Polypoidal Choroidal Vasculopathy: 12-Month Results of the PLANET Study
Author Affiliations & Notes
  • Won Ki Lee
    Ophthalmology, Seoul St. Mary's Hospital, Catholic Medical Center, Seoul, Korea (the Republic of)
  • Yuichiro Ogura
    Department of Ophthalmology and Visual Sciences, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
  • Tomohiro Iida
    Department of Ophthalmology, Tokyo Women's Medical University, Tokyo, Japan
  • Shih-Jen Chen
    Taipei Veterans General Hospital, Taipei, Taiwan
  • Tien Yin Wong
    Singapore National Eye Centre, Singapore, Singapore
    National University of Singapore, Singapore, Singapore
  • Paul Mitchell
    Department of Ophthalmology, University of Sydney, Sydney, New South Wales, Australia
  • Tatsuro Ishibashi
    Department of Ophthalmology , Kyushu University Hospital, Fukuoka, Japan
  • eric zhang
    Bayer Pharmaceuticals Healthcare, Beijing, China
  • Sergio Leal
    Bayer Pharmaceuticals Healthcare, Berlin, Germany
  • Footnotes
    Commercial Relationships   Won Ki Lee, Allergan (R), Bayer Healthcare Pharmaceuticals (C), Novartis Pharmaceuticals Corporation (C), Santen, Inc. (C); Yuichiro Ogura, Bayer Pharmaceuticals Healthcare (C); Tomohiro Iida, Bayer Pharmaceuticals Healthcare (C); Shih-Jen Chen, Bayer Pharmaceuticals Healthcare (C); Tien Yin Wong, Bayer Pharmaceuticals Healthcare (C); Paul Mitchell, Bayer Pharmaceuticals Healthcare (C); Tatsuro Ishibashi, Bayer Pharmaceuticals Healthcare (C); eric zhang, Bayer Pharmaceuticals Healthcare (E); Sergio Leal, Bayer Pharmaceuticals Healthcare (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 1199. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      Won Ki Lee, Yuichiro Ogura, Tomohiro Iida, Shih-Jen Chen, Tien Yin Wong, Paul Mitchell, Tatsuro Ishibashi, eric zhang, Sergio Leal; Efficacy and Safety of Intravitreal Aflibercept in Polypoidal Choroidal Vasculopathy: 12-Month Results of the PLANET Study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):1199.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : The aim of the PLANET study is to evaluate the efficacy, safety, and tolerability of intravitreal aflibercept injection (IAI) monotherapy compared with IAI plus photodynamic therapy (PDT) in patients with PCV.

Methods : PLANET was a randomized, double-masked, sham-controlled, Phase 3b/4 study conducted at 62 sites primarily in Asia. The primary endpoint was the mean change in best-corrected visual acuity from baseline to Week 52. All patients received IAI 2 mg every month for the first 3 months. At Week 12 all patients were randomized 1:1 to IAI 2 mg plus sham PDT (monotherapy) or IAI 2 mg plus active PDT groups. Stratification at randomization was based on qualification for rescue therapy at Week 12 and by ethnicity (Japanese or non-Japanese).

Results : Overall 333 patients were recruited, and 318 were randomized (full analysis set). Baseline demographics/characteristics were similar between groups: 69.8% were male; mean age was 70.6 years. For the primary endpoint, IAI monotherapy (+10.7 letters) was noninferior to IAI plus active PDT (+10.8 letters) at Week 52 (95% CI [–2.9 to 1.6]). The vast majority of patients in the IAI monotherapy and IAI plus active PDT groups did not require rescue therapy (87.9% vs 85.7%, respectively; P=0.84]) and received only IAI 2 mg 8 weekly after 3 monthly doses. The proportions of patients without active polyps at Week 52 were 81.7% and 88.9%. Rates of complete polyp regression by indocyanine green angiography were similar for patients in the IAI monotherapy and IAI plus active PDT groups at Week 52 (38.9% vs 44.8%, respectively; P=0.32). The incidence of ocular treatment-emergent adverse events (AEs) was similar in the IAI monotherapy and IAI plus active PDT groups at Week 52 (31.2% vs 29.2%, respectively). The most common ocular AEs in each group were conjunctival hemorrhage (5.1%) and dry eye (5.6%), respectively. There were no differences in the incidence of Anti-Platelet Trialists Collaboration–defined arterial thromboembolic events between treatments.

Conclusions : IAI monotherapy is an effective treatment for patients with PCV, with no need for rescue therapy in >85% of patients. In this study, IAI monotherapy was noninferior to IAI plus active PDT and more than 80% of patients had no signs of polyp activity at Week 52. The safety profile of IAI was consistent with that seen in previous studies.

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

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×