EXTEND III: Efficacy and safety of ranibizumab in South Korean and Taiwanese patients with subfoveal CNV secondary to AMD

Background The purpose of this study was to investigate the efficacy and safety of intravitreal ranibizumab 0.5 mg in South Korean and Taiwanese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Methods This was a 12-month, open-label, si...

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Published in:Graefe's archive for clinical and experimental ophthalmology 2012-10, Vol.250 (10), p.1467-1476
Main Authors: Kwon, Oh-Woong, Lee, Fenq Lih, Chung, Hum, Lai, Chi-Chun, Sheu, Shwu-Jiuan, Yoon, Young-Hee
Format: Article
Language:English
Subjects:
Aged
Angiogenesis Inhibitors - administration & dosage
Angiogenesis Inhibitors - adverse effects
Antibodies, Monoclonal, Humanized - administration & dosage
Antibodies, Monoclonal, Humanized - adverse effects
Capillary Permeability
Choroidal Neovascularization - drug therapy
Choroidal Neovascularization - etiology
Choroidal Neovascularization - physiopathology
Female
Fluorescein - metabolism
Fovea Centralis
Humans
Intravitreal Injections
Macular Degeneration - complications
Macular Degeneration - drug therapy
Macular Degeneration - physiopathology
Male
Medical Ophthalmology
Medicine
Medicine & Public Health
Middle Aged
Ophthalmology
Ranibizumab
Republic of Korea
Taiwan
Treatment Outcome
Visual Acuity - physiology
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Summary:Background The purpose of this study was to investigate the efficacy and safety of intravitreal ranibizumab 0.5 mg in South Korean and Taiwanese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Methods This was a 12-month, open-label, single-arm, multi-center, phase III study. Ninety-five patients (Taiwanese: 51; South Korean: 44) were included in the study. Key outcome measures assessed included: mean change in best-corrected visual acuity (BCVA) from baseline to months 4 (primary endpoint) and 12 (secondary endpoint); other secondary endpoints comprising categorized mean change in BCVA from baseline at month 4 and month 12, mean change in BCVA from baseline at month 4 and month 12 per baseline characteristics; and incidence of ocular and non-ocular adverse events and serious adverse events (SAEs) at month 12. Results The mean BCVA change improved significantly ( p  
ISSN:0721-832X
1435-702X
DOI:10.1007/s00417-012-1970-3