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REAL-WORLD EFFECTIVENESS AND SAFETY OF RANIBIZUMAB TREATMENT IN PATIENTS WITH AND WITHOUT POLYPOIDAL CHOROIDAL VASCULOPATHY: Twelve-Month Results From the LUMINOUS Study

Koh A 1 , Lai TYY 2 , Wei WB 3 , Mori R 4 , Wakiyama H 5 , Park KH 6 Show all authors , Ngah F 7 , Macfadden W 8 , Dunger-Baldauf C 8 , Parikh S 8 , LUMINOUS study steering committee

Affiliations 

  • 1 Eye and Retina Surgeons, Camden Medical Centre, Singapore, Singapore
  • 2 Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong
  • 3 Beijing Ophthalmology and Visual Science Key Lab, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
  • 4 Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan
  • 5 The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan
  • 6 Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University, College of Medicine, Kyeonggi, Republic of Korea
  • 7 Department of Ophthalmology, Hospital Selayang, Lebuhraya Selayang-Kepong, Batu Caves, Selangor, Malaysia; and
  • 8 Novartis Pharma AG, Basel, Switzerland
Retina, 2020 Aug;40(8):1529-1539.
PMID: 31385918 DOI: 10.1097/IAE.0000000000002624

Abstract

PURPOSE: To evaluate the real-world effectiveness and safety of intravitreal ranibizumab 0.5 mg in treatment-naive patients with and without polypoidal choroidal vasculopathy (PCV).

METHODS: Assessment of neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the LUMINOUS study. Outcome measures were visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events.

RESULTS: At baseline, 572 and 5,644 patients were diagnosed with and without PCV, respectively. The mean visual acuity gain from baseline at Month 12 in the PCV and non-PCV groups was +5.0 and +3.0 letters, respectively; these gains were achieved with a mean of 4.4 and 5.1 ranibizumab injections. Eighty percent of PCV patients and 72.2% of non-PCV patients who had baseline visual acuity ≥73 letters maintained this level of vision at Month 12; 20.6% and 17.9% of patients with baseline visual acuity <73 letters achieved visual acuity ≥73 letters in these groups. Greater reductions in central retinal thickness from baseline were also observed for the PCV group versus the non-PCV group. The rate of serious ocular adverse events was 0.7% (PCV group) and 0.9% (non-PCV group).

CONCLUSION: LUMINOUS confirms the effectiveness and safety of ranibizumab in treatment-naive patients with PCV.

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

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