April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Efficacy and Safety of Intravitreal Aflibercept for Choroidal Neovascularization Secondary to Pathological Myopia: 48-week Results of MYRROR Study
Author Affiliations & Notes
  • Tien Y Wong
    Singapore Eye Research Institute, Singapore, Singapore
    Ophthalmology Academic Clinical Program, Duke-NUS Graduate Medical School, Singapore, Singapore
  • Tatsuro Ishibashi
    Department of Ophthalmology, Kyushu University, Fukuoka, Japan
  • Kyoko Ohno-Matsui
    Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan
  • Yasushi Ikuno
    Department of Ophthalmology, Osaka University Hospital, Osaka, Japan
  • Jean-Francois Korobelnik
    Service d’ophtalmologie, Hôpital Pellegrin—CHU de Bordeaux, Bordeaux, France
  • Brigitte Stemper
    Bayer Healthcare Pharmaceuticals, Berlin, Germany
  • Yoshimi Matsuda
    Bayer Healthcare Pharmaceuticals, Osaka, Japan
  • Tummy Li
    Bayer Healthcare Pharmaceuticals, Beijing, China
  • Robert Vitti
    Regeneron Pharmaceuticals, Inc, Tarrytown, NY
  • Oliver Zeitz
    Bayer Healthcare Pharmaceuticals, Berlin, Germany
  • Footnotes
    Commercial Relationships Tien Wong, Allergan (C), Bayer (C), GlaxoSmithKline (F), Novartis (C), Pfizer (C), Roche (F); Tatsuro Ishibashi, Bayer (C); Kyoko Ohno-Matsui, Bayer (C); Yasushi Ikuno, Bayer (C), TOMEY (F), Topcon (F); Jean-Francois Korobelnik, Alcon (C), Allergan (C), Bayer (C), Carl Zeiss Meditec (C), Novartis (C), Roche (C), Thea (C); Brigitte Stemper, Bayer (E); Yoshimi Matsuda, Bayer (E); Tummy Li, Bayer (E); Robert Vitti, Regeneron Pharmaceuticals, Inc. (E); Oliver Zeitz, Bayer (E)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 4960. doi:
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      Tien Y Wong, Tatsuro Ishibashi, Kyoko Ohno-Matsui, Yasushi Ikuno, Jean-Francois Korobelnik, Brigitte Stemper, Yoshimi Matsuda, Tummy Li, Robert Vitti, Oliver Zeitz, ; Efficacy and Safety of Intravitreal Aflibercept for Choroidal Neovascularization Secondary to Pathological Myopia: 48-week Results of MYRROR Study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):4960.

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

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Abstract
 
Purpose
 

To evaluate the efficacy and safety of intravitreal aflibercept for treatment of choroidal neovascularization (CNV) secondary to pathological myopia.

 
Methods
 

MYRROR is a 48-week, Phase 3, multicenter, randomized, double-masked, sham-controlled study in which patients with myopic CNV were randomized 3:1 to aflibercept 2 mg or sham treatment. Patients assigned aflibercept received a single injection at baseline followed by additional injections in case of CNV persistence or recurrence with monthly assessments until Week 44. Confirmatory analyses were performed for “mean change in best-corrected visual acuity” at Week 24 (primary endpoint) and for the “proportion of patients gaining ≥15 letters from baseline” at Week 24 (secondary endpoint). From Week 24, patients receiving sham were switched to aflibercept 2 mg.

 
Results
 

122 patients were randomized to aflibercept (n=91) or sham (n=31). Baseline demographics were similar. At Week 24, patients in the aflibercept group gained a mean 12.1 letters compared to a loss of 2 letters in sham (P<0.0001). 38.9% of patients in the aflibercept group vs 9.7% in sham gained ≥15 letters from baseline (P=0.0001). By Week 48, the aflibercept 2-mg group gained a mean 13.5 letters (50% gained ≥15 letters). Patients in the aflibercept 2-mg group received a median of 2 injections (range 1-3) in the 1st quarter of the study. In the 2nd to the 4th quarter the median number of injections was 0 (range 0-3). At Week 48 the sham/aflibercept group gained 3.9 letters from baseline (29% gained ≥15 letters) with a median 2 active injections (range 0-3) in Week 24-32 and 1 (range 0-3) in Week 36-44. The most commonly reported (≥2%) treatment-emergent adverse events (TEAEs) were nasopharyngitis, conjunctival hemorrhage, dry eye, eye pain, and headache. From Week 0-48 the incidence of ocular TEAEs was similar with 37.4% in AFL 2-mg vs 38.7% in the sham/aflibercept 2-mg group. The majority of TEAEs in both groups were mild, with no deaths.

 
Conclusions
 

Intravitreal aflibercept was well tolerated and resulted in a clinically meaningful improvement in patients with myopic CNV. Most injections were given in the 1st quarter of the study with minimal reinjections over subsequent quarters, while vision benefits were maintained or extended. Myopic CNV can be successfully managed with short-term intravitreal aflibercept treatment.

 
Keywords: 453 choroid: neovascularization • 605 myopia • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials  
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