June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Ranibizumab in pigment epithelial tears secondary to AMD – a prospective, multicenter, investigator-initiated trial (RIP Study)
Author Affiliations & Notes
  • Tim U Krohne
    Ophthalmology, University of Bonn, Bonn, Germany
  • Petra P Fang
    Ophthalmology, University of Bonn, Bonn, Germany
  • Akio Oishi
    Ophthalmology, University of Bonn, Bonn, Germany
  • Seleman Bedar
    Ophthalmology, University of Bonn, Bonn, Germany
  • Philipp K. R. Heymer
    Ophthalmology, University of Bonn, Bonn, Germany
  • Christoph Roman Clemens
    Ophthalmology, University of Muenster, Muenster, Germany
  • Susanna König
    Ophthalmology, Ludwig Maximilian University of Munich, Munich, Germany
  • Nicole Eter
    Ophthalmology, University of Muenster, Muenster, Germany
  • Armin Wolf
    Ophthalmology, Ludwig Maximilian University of Munich, Munich, Germany
  • Frank G Holz
    Ophthalmology, University of Bonn, Bonn, Germany
  • Footnotes
    Commercial Relationships   Tim Krohne, Alimera Sciences (C), Alimera Sciences (R), Bayer (C), Bayer (R), Heidelberg Engineering (R), Novartis (F), Novartis (C), Novartis (R); Petra Fang, None; Akio Oishi, Alcon (F), Bayer (R), Novartis (R); Seleman Bedar, None; Philipp Heymer, None; Christoph Clemens, Bayer (F), Bayer (C), Bayer (R), Heidelberg Engineering (R), Novartis (F), Novartis (C), Novartis (R); Susanna König, None; Nicole Eter, Alimera Sciences (C), Allergan (F), Allergan (C), Bausch + Lomb (C), Bayer (F), Bayer (C), Bayer (R), Heidelberg Engineering (R), Novartis (F), Novartis (C), Novartis (R), Roche (C); Armin Wolf, Bayer (F), DORC (R), Gensight (F), Novartis (F), Novartis (C), Novartis (R), Oertli (R), Ophthotech (F), Optos (C), Optos (R), Roche (F); Frank Holz, Acucela (F), Acucela (C), Allergan (F), Allergan (R), Bayer (F), Bayer (C), Bayer (R), Bioeq (F), Bioeq (C), Boehringer-Ingelheim (C), Genentech (F), Genentech (C), Heidelberg Engineering (F), Heidelberg Engineering (C), Merz (C), NightstarX (F), Novartis (F), Novartis (C), Novartis (R), Optos (F), Pixium (F), Roche (F), Roche (C), Thea (C), Zeiss (F)
  • Footnotes
    Support  Novartis Pharma GmbH, Nuremberg, Germany
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 3763. doi:
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    • Get Citation

      Tim U Krohne, Petra P Fang, Akio Oishi, Seleman Bedar, Philipp K. R. Heymer, Christoph Roman Clemens, Susanna König, Nicole Eter, Armin Wolf, Frank G Holz; Ranibizumab in pigment epithelial tears secondary to AMD – a prospective, multicenter, investigator-initiated trial (RIP Study). Invest. Ophthalmol. Vis. Sci. 2017;58(8):3763.

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

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Abstract

Purpose : Retinal pigment epithelium (RPE) tears represent a complication of neovascular age-related macular degeneration (AMD), most commonly in association with pigment epithelial detachments. The efficacy of intravitreal anti-VEGF therapy in neovascular AMD has been demonstrated in various prospective large-scale clinical trials, whereby the presence of an RPE tear constituted an exclusion criterion. Thus, the efficacy of anti-VEGF therapy in this AMD subtype is unclear. This study aims to assess efficacy of ranibizumab in RPE tears.

Methods : In a prospective, multicenter, investigator-initiated trial (Ranibizumab In Pigment epithelial tears secondary to AMD - RIP Study, EudraCT no. 2011-005807-33), the morphological and functional effects of monthly intravitreal injections of ranibizumab (0.5 mg) over 12 months in patients diagnosed with an RPE tear secondary to AMD were investigated. Study visits included assessment of best-corrected visual acuity (BCVA) according to ETDRS protocol, color fundus photography, spectral domain optical coherence tomography (OCT), fundus autofluorescence, fluorescein and indocyanin green angiography, and microperimetry. Quality of life was assessed using the NEI-VFQ-25. Paired Student’s t test was employed for statistical analyses.

Results : Twentyfour eyes of 24 patients (mean age 79.2 years, age range 69-94 years) were included in the study. Central retinal thickness (ILM to BM) in OCT decreased from 612 µm (± 202) to 436 µm (± 171; p < 0.0001) over the 12 months study period. Mean BCVA at baseline and at final visit was 50.0 (± 18.8) and 52.9 ETDRS letters (± 19.7; p = 0.39), respectively, thus demonstrating a stabilization of mean BCVA under ranibizumab therapy. One patient (4%) experienced a visual loss of ≥ 15 ETDRS letters, 2 patients (8%) gained ≥ 15 letters, and in 21 patients (88%) BCVA remained stable within ± 15 letters. In contrast, a comparable historical control cohort of patients with untreated RPE tears exhibited a progressive and significant decline of mean BCVA over 12 months and beyond (M. Gutfleisch et al., Eye 2011;25:1181-6).

Conclusions : The RIP Study provides prospective results of morphological and functional efficacy parameters of ranibizumab therapy in RPE tears, demonstrating BCVA stabilization over 12 months. The results will help to establish treatment recommendations for this understudied AMD subphenotype.

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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