June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Regularity of treatment in nAMD: 12-month results of the PERSEUS and RAINBOW studies
Author Affiliations & Notes
  • Carsten Framme
    Ophthalmology, Medizinische Hochschule Hannover, Hannover, Germany
  • Laurent KODJIKIAN
    Ophthalmology, Hopital de la Croix-Rousse, Lyon, France
  • Footnotes
    Commercial Relationships   Carsten Framme, Allergan (R), Bayer (C), Bayer (R), Heidelberg Engineering (R), Novartis (F), Novartis (R), Zeiss (R); Laurent KODJIKIAN, Alcon (C), Allergan (C), Bayer (C), Novartis (C), Théa (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 425. doi:
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      Carsten Framme, Laurent KODJIKIAN; Regularity of treatment in nAMD: 12-month results of the PERSEUS and RAINBOW studies. Invest. Ophthalmol. Vis. Sci. 2017;58(8):425.

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

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Abstract

Purpose : PERSEUS and RAINBOW are the first studies to analyze the real-life use of intravitreal aflibercept injections (IAI) in neovascular macular degeneration (nAMD) in Germany and France, respectively. The aim of these analyses was to assess the impact of regular treatment approach (PERSEUS; loading dose of 2 mg IAI once a month for 3 months, followed by 2 mg IAI every 2 months) and loading doses (RAINBOW; 3 IAI within 120 days) on visual acuity (VA) after 12 months of treatment in 2 different healthcare systems.

Methods : PERSEUS is a prospective observational study in Germany. Inclusion criteria were patients diagnosed with nAMD who received treatment with IAI in accordance with European IAI product labeling. In total, 874 patients were included in the 12-month analysis. The 12-month results from the anti-VEGF treatment-naïve cohort (n=451) stratified based on the regularity of treatment (regular cohort [loading doses, followed by 2 mg IAI every 2 months] and irregular cohort [patients who didn’t meet the criteria for regular cohort]) are presented. RAINBOW is a retrospective and prospective observational study in France. Inclusion criteria were patients diagnosed with nAMD receiving treatment with 2 mg IAI as first-line therapy. An interim analysis was performed after 12 months for 196 patients. Furthermore, the subgroup who received 3 loading doses within 120 days (n=179) was analyzed.

Results : PERSEUS: baseline mean age was 77.4±7.7 years and VA was 53.1±18.2 letters. Patients in the regular cohort (33%) showed mean±SD VA improvement of 8.1±17.7 letters (irregular cohort [67%]: 4.2±17.0; all naïve patients combined: 5.5±17.3). Mean number of injections was 5.8±2.2, mean number of visits was 8.9±4.1.
RAINBOW: baseline mean age was 78.8±7.7 years and VA was 57.7±18.3 letters. Mean VA improvement was 6.2±16.8 in all patients. In the subgroup receiving the loading doses, mean VA gain was 7.4±15.8. In all patients, the mean number of injections was 6.3±2.0, mean number of visits was 9.9±1.7.
In PERSEUS and RAINBOW, respectively, treatment-related treatment-emergent adverse events (TEAEs) occurred in 3.4% and 2.6% of patients. No endophthalmitis cases were observed in either study.

Conclusions : In both healthcare systems within a 12-month treatment period, patients benefited most when receiving 3 IAI loading doses or when such was combined with IAI in regular injection intervals, as opposed to irregular treatment.

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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