One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study
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 p...
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| Format: | Article |
| Language: | English |
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Press of International Journal of Ophthalmology (IJO PRESS)
2018-11-01
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| Series: | International Journal of Ophthalmology |
| Subjects: | |
| Online Access: | http://www.ijo.cn/en_publish/2018/11/20181111.pdf |
| _version_ | 1811278248063008768 |
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| author | San-Ni Chen Cheng-Kuo Cheng Ling Yeung Jiann-Torng Chen Wei-Chun Chan Jorn-Hon Liu Shwu-Jiuan Sheu Wen-Chuan Wu Chi-Chun Lai |
| author_facet | San-Ni Chen Cheng-Kuo Cheng Ling Yeung Jiann-Torng Chen Wei-Chun Chan Jorn-Hon Liu Shwu-Jiuan Sheu Wen-Chuan Wu Chi-Chun Lai |
| author_sort | San-Ni Chen |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-13T00:31:22Z |
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| id | doaj.art-94dc67843eca45ce9d820ca22eada1b9 |
| institution | Directory Open Access Journal |
| issn | 2222-3959 2227-4898 |
| language | English |
| last_indexed | 2024-04-13T00:31:22Z |
| publishDate | 2018-11-01 |
| publisher | Press of International Journal of Ophthalmology (IJO PRESS) |
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| series | International Journal of Ophthalmology |
| spelling | doaj.art-94dc67843eca45ce9d820ca22eada1b92022-12-22T03:10:27ZengPress of International Journal of Ophthalmology (IJO PRESS)International Journal of Ophthalmology2222-39592227-48982018-11-0111111802180810.18240/ijo.2018.11.11One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL studySan-Ni Chen0Cheng-Kuo Cheng1Ling Yeung2Jiann-Torng Chen3Wei-Chun Chan4Jorn-Hon Liu5Shwu-Jiuan Sheu6Wen-Chuan Wu7Chi-Chun Lai8Changhua Christian Hospital, Changhua, Taiwan 50094, China; College of Medicine, Chung Shan Medical University, Taichung City, Taiwan 40246, ChinaShin Kong Wu Ho-Su Memorial Hospital, Shilin District, Taipei City, Taiwan 11101, ChinaChang Gung Memorial Hospital-Keelung, Anle District, Keelung City, Taiwan 204, ChinaTri-Service General Hospital, Chenggong Road, Taipei City, Taiwan 11490, ChinaMackay Memorial Hospital, Zhongshan District, Taipei City, Taiwan 813, ChinaCheng Hsin General Hospital, Beitou District, Taipei City, Taiwan 112, ChinaKaohsiung Veterans General Hospital, Zuoying District, Kaohsiung City, Taiwan 81362, ChinaKaohsiung Medical University Chung-Ho Memorial Hospital, Sanmin District, Kaohsiung City, Taiwan 807, ChinaChang Gung Memorial Hospital-Linkou, Guishan District, Taoyuan City, Taiwan 333, ChinaAIM: 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.http://www.ijo.cn/en_publish/2018/11/20181111.pdfobservational studypolypoidal choroidal vasculopathyranibizumabTaiwanvisual acuityvisual acuity |
| spellingShingle | San-Ni Chen Cheng-Kuo Cheng Ling Yeung Jiann-Torng Chen Wei-Chun Chan Jorn-Hon Liu Shwu-Jiuan Sheu Wen-Chuan Wu Chi-Chun Lai One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study International Journal of Ophthalmology observational study polypoidal choroidal vasculopathy ranibizumab Taiwan visual acuity visual acuity |
| title | One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study |
| title_full | One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study |
| title_fullStr | One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study |
| title_full_unstemmed | One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study |
| title_short | One-year real-world outcomes of ranibizumab 0.5 mg treatment in Taiwanese patients with polypoidal choroidal vasculopathy: a subgroup analysis of the REAL study |
| title_sort | one year real world outcomes of ranibizumab 0 5 mg treatment in taiwanese patients with polypoidal choroidal vasculopathy a subgroup analysis of the real study |
| topic | observational study polypoidal choroidal vasculopathy ranibizumab Taiwan visual acuity visual acuity |
| url | http://www.ijo.cn/en_publish/2018/11/20181111.pdf |
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