Intravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization: The MYRROR Study.
OBJECTIVE
To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV).


METHODS
An international, phase III, multicenter, randomized, double-masked, sham-controlled study.


METHODS
Patients aged ≥ 18 years with high myopia (≤-6.0 diopters or axial length of ≥ 26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73-35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included.


METHODS
Patients were randomized 3:1 to intravitreal aflibercept or sham. In the intravitreal aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept (if disease persisted/recurred) or sham injection every 4 weeks.


METHODS
Mean change in BCVA from baseline to week 24.


RESULTS
A total of 122 patients were randomized to intravitreal aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal aflibercept and sham groups gained 12.1 and lost 2 letters, respectively (P < 0.0001). By week 48, patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained 13.5 and 3.9 letters. Patients in the intravitreal aflibercept group received 2 injections (median) in the first study quarter (week 0-8). Median number of injections in quarters 2 to 4 was 0. Patients in the "sham/intravitreal aflibercept" group received 2 and 1 (median) intravitreal aflibercept injections in quarters 3 and 4. Central retinal thickness improved in parallel with visual gains. Incidence of ocular adverse events was similar in both groups through week 48 (37.4% vs. 38.7); most were assessed by investigators as mild. No deaths occurred.


CONCLUSIONS
Intravitreal aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal aflibercept should be considered as a treatment option for myopic CNV.
Department of Ophthalmology, Osaka University School of Medicine, Osaka, Japan.
Yasushi
Y
Ikuno
Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan.
Kyoko
K
Ohno-Matsui
Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Graduate Medical School, National University of Singapore, Singapore.
Tien Yin
TY
Wong
Service d'ophtalmologie, Hopital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France.
Jean-Francois
JF
Korobelnik
Regeneron Pharmaceuticals, Inc., Tarrytown, New York.
Robert
R
Vitti
Bayer HealthCare Pharmaceuticals, Beijing, China.
Tummy
T
Li
Bayer HealthCare Pharmaceuticals, Berlin, Germany; Department of Neurology, University of Erlangen-Nürnberg, Erlangen, Germany.
Brigitte
B
Stemper
Bayer HealthCare Pharmaceuticals, Berlin, Germany; Department of Neurodegeneration, Center of Neurology, University Hospital of Tübingen, and Hertie Institute for Clinical Brain Research, Tübingen, Germany.
Friedrich
F
Asmus
Bayer HealthCare Pharmaceuticals, Berlin, Germany; Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Oliver
O
Zeitz
Department of Ophthalmology, Kyushu University, Fukuoka, Japan. Electronic address: ishi@eye.med.kyushu-u.ac.jp.
Tatsuro
T
Ishibashi
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D047728:Myopia, Degenerative / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor