Yasushi Ikuno1, Kyoko Ohno-Matsui2, Tien Yin Wong3, Jean-Francois Korobelnik4, Robert Vitti5, Tummy Li6, Brigitte Stemper7, Friedrich Asmus8, Oliver Zeitz9, Tatsuro Ishibashi10. 1. Department of Ophthalmology, Osaka University School of Medicine, Osaka, Japan. 2. Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan. 3. Singapore Eye Research Institute, Singapore National Eye Center, Duke-NUS Graduate Medical School, National University of Singapore, Singapore. 4. Service d'ophtalmologie, Hopital Pellegrin-CHU de Bordeaux, Bordeaux, France; Université Bordeaux Segalen, Bordeaux, France; INSERM, ISPED, Centre INSERM U897-Epidemiologie-Biostatistique, Bordeaux, France. 5. Regeneron Pharmaceuticals, Inc., Tarrytown, New York. 6. Bayer HealthCare Pharmaceuticals, Beijing, China. 7. Bayer HealthCare Pharmaceuticals, Berlin, Germany; Department of Neurology, University of Erlangen-Nürnberg, Erlangen, Germany. 8. Bayer HealthCare Pharmaceuticals, Berlin, Germany; Department of Neurodegeneration, Center of Neurology, University Hospital of Tübingen, and Hertie Institute for Clinical Brain Research, Tübingen, Germany. 9. Bayer HealthCare Pharmaceuticals, Berlin, Germany; Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. 10. Department of Ophthalmology, Kyushu University, Fukuoka, Japan. Electronic address: ishi@eye.med.kyushu-u.ac.jp.
Abstract
PURPOSE: To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). DESIGN: An international, phase III, multicenter, randomized, double-masked, sham-controlled study. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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.
RCT Entities:
PURPOSE: To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). DESIGN: An international, phase III, multicenter, randomized, double-masked, sham-controlled study. PARTICIPANTS: 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. MAIN OUTCOME MEASURES: 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.
Authors: D S C Ng; C Y L Cheung; F O Luk; S Mohamed; M E Brelen; J C S Yam; C W Tsang; T Y Y Lai Journal: Eye (Lond) Date: 2016-04-08 Impact factor: 3.775
Authors: João Coelho; André Ferreira; Ana Carolina Abreu; Sílvia Monteiro; Maria João Furtado; Miguel Gomes; Miguel Lume Journal: Graefes Arch Clin Exp Ophthalmol Date: 2021-03-21 Impact factor: 3.117