San-Ni Chen1,2, Cheng-Kuo Cheng3, Ling Yeung4, Jiann-Torng Chen5, Wei-Chun Chan6, Jorn-Hon Liu7, Shwu-Jiuan Sheu8, Wen-Chuan Wu9, Chi-Chun Lai10. 1. Changhua Christian Hospital, Changhua, Taiwan 50094, China. 2. College of Medicine, Chung Shan Medical University, Taichung City, Taiwan 40246, China. 3. Shin Kong Wu Ho-Su Memorial Hospital, Shilin District, Taipei City, Taiwan 11101, China. 4. Chang Gung Memorial Hospital-Keelung, Anle District, Keelung City, Taiwan 204, China. 5. Tri-Service General Hospital, Chenggong Road, Taipei City, Taiwan 11490, China. 6. Mackay Memorial Hospital, Zhongshan District, Taipei City, Taiwan 813, China. 7. Cheng Hsin General Hospital, Beitou District, Taipei City, Taiwan 112, China. 8. Kaohsiung Veterans General Hospital, Zuoying District, Kaohsiung City, Taiwan 81362, China. 9. Kaohsiung Medical University Chung-Ho Memorial Hospital, Sanmin District, Kaohsiung City, Taiwan 807, China. 10. Chang Gung Memorial Hospital-Linkou, Guishan District, Taoyuan City, Taiwan 333, China.
Abstract
AIM: To assess the effectiveness and safety of ranibizumab 0.5 mg in Taiwanese patients with polypoidal choroidal vasculopathy (PCV) by performing a retrospective exploratory subgroup analysis of the REAL study. METHODS: REAL was a 12-month, observational, prospective, non-interventional phase IV post-marketing surveillance study conducted at 9 centers in Taiwan. The study collected data as part of the routine patient visits from the medical records of patients with neovascular age-related macular degeneration treated with ranibizumab 0.5 mg according to local standard medical practice and local label and/or reimbursement guidelines. The presence of PCV at baseline was determined using indocyanine green angiography. RESULTS: At baseline, PCV was diagnosed in 64 of the 303 enrolled patients (21.1%). Of these, 41 patients (64.1%) had received prior treatment; 15 (23.4%) patients had received ranibizumab. The intent-to-treat population included 58 patients; 47 (80%) who received ranibizumab and 11 (20%) who received ranibizumab plus photodynamic therapy (PDT; 9 patients received once, 2 patients received twice). Bevacizumab was used as a concomitant medication in a similar percentage of patients who received ranibizumab (43%, n=20) or ranibizumab plus PDT (45%, n=5). In patients who received ranibizumab, visual acuity (VA) at baseline was 50.1±12.9 Early Treatment Diabetic Retinopathy Study letters, and the gain at month 12 was 1.1±17.8 letters. In patients who received ranibizumab plus PDT, VA at baseline was 51.4±15.9 letters, and there was a marked gain in VA at month 12 (14.0±9.2 letters, P=0.0009). In the intent-to-treat population, the reduction in central retinal subfield thickness from baseline at month 12 was 69.6±122.6 µm (baseline: 310.8±109.8 µm, P=0.0004). The safety results were consistent with the well-characterized safety profile of ranibizumab. CONCLUSION: In real-world settings, ranibizumab 0.5 mg treatment for 12mo results in maintenance of VA and reduction in central retinal subfield thickness in Taiwanese patients with PCV. Improvements in VA are observed in patients who received ranibizumab plus PDT. There are no new safety findings.
AIM: To assess the effectiveness and safety of ranibizumab 0.5 mg in Taiwanese patients with polypoidal choroidal vasculopathy (PCV) by performing a retrospective exploratory subgroup analysis of the REAL study. METHODS: REAL was a 12-month, observational, prospective, non-interventional phase IV post-marketing surveillance study conducted at 9 centers in Taiwan. The study collected data as part of the routine patient visits from the medical records of patients with neovascular age-related macular degeneration treated with ranibizumab 0.5 mg according to local standard medical practice and local label and/or reimbursement guidelines. The presence of PCV at baseline was determined using indocyanine green angiography. RESULTS: At baseline, PCV was diagnosed in 64 of the 303 enrolled patients (21.1%). Of these, 41 patients (64.1%) had received prior treatment; 15 (23.4%) patients had received ranibizumab. The intent-to-treat population included 58 patients; 47 (80%) who received ranibizumab and 11 (20%) who received ranibizumab plus photodynamic therapy (PDT; 9 patients received once, 2 patients received twice). Bevacizumab was used as a concomitant medication in a similar percentage of patients who received ranibizumab (43%, n=20) or ranibizumab plus PDT (45%, n=5). In patients who received ranibizumab, visual acuity (VA) at baseline was 50.1±12.9 Early Treatment Diabetic Retinopathy Study letters, and the gain at month 12 was 1.1±17.8 letters. In patients who received ranibizumab plus PDT, VA at baseline was 51.4±15.9 letters, and there was a marked gain in VA at month 12 (14.0±9.2 letters, P=0.0009). In the intent-to-treat population, the reduction in central retinal subfield thickness from baseline at month 12 was 69.6±122.6 µm (baseline: 310.8±109.8 µm, P=0.0004). The safety results were consistent with the well-characterized safety profile of ranibizumab. CONCLUSION: In real-world settings, ranibizumab 0.5 mg treatment for 12mo results in maintenance of VA and reduction in central retinal subfield thickness in Taiwanese patients with PCV. Improvements in VA are observed in patients who received ranibizumab plus PDT. There are no new safety findings.
Authors: Kai Tang; Jun-Kang Si; Da-Dong Guo; Yan Cui; Yu-Xiang Du; Xue-Mei Pan; Hong-Sheng Bi Journal: Int J Ophthalmol Date: 2015-10-18 Impact factor: 1.779
Authors: Colin S Tan; Wei Kiong Ngo; Louis W Lim; Nikolle W Tan; Tock H Lim Journal: Graefes Arch Clin Exp Ophthalmol Date: 2016-05-03 Impact factor: 3.117
Authors: Tock H Lim; Timothy Y Y Lai; Kanji Takahashi; Tien Y Wong; Lee-Jen Chen; Paisan Ruamviboonsuk; Colin S Tan; Won Ki Lee; Chui Ming Gemmy Cheung; Nor Fariza Ngah; Ramune Patalauskaite; Philippe Margaron; Adrian Koh Journal: JAMA Ophthalmol Date: 2020-09-01 Impact factor: 7.389