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

Chen, San-Ni; Cheng, Cheng-Kuo; Yeung, Ling; Chen, Jiann‐Torng; Chan, Wei-Chun; Liu, Jorn‐Hon; Sheu, Shwu‐Jiuan; Wu, Wen-Chuan; Lai, Chi-Chun

doi:10.18240/ijo.2018.11.11

Cited by 8 publications

(11 citation statements)

References 26 publications

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“…The RENOWNED and REAL studies were multicenter, open-label, single-arm, prospective, observational, non-interventional studies investigating the treatment of ranibizumab in nAMD patients (N = 202 and 228, respectively) through a one-year follow-up period 28 , 29 . The PCV cases were considered as a distinctive type of nAMD, the treatment for which included receiving either three reimbursed anti-VEGF injections or a self-paid combination therapy program for one year.…”

Section: Methodsmentioning

confidence: 99%

“…Collected data included ICGA/FA images at baseline, BCVA, central retinal subfield thickness, presence of subretinal fluid (SRF) using optical coherence tomography (OCT), and other fundus parameters at baseline and at visits during months 3 and 12. The clinical study reports were finalized for RENOWNED 28 in April 2015 and for REAL 29 in December 2013.…”

Section: Methodsmentioning

confidence: 99%

“…The National Health Insurance of Taiwan reimbursed three injections of ranibizumab per year. For combination therapy, PDT was implemented as a standard regimen (verteporfin dose 6 mg/m 2 ; light dose, 50 J/cm 2 , 600 mW/cm 2 , 83 s; wavelength, 689 nm) 28 , 29 . Patients meeting the following criteria were enrolled: (1) PCV diagnosed by ICGA at baseline; and (2) participated at a hospital with ≥ 5 intention-to-treat (ITT) PCV cases to demonstrate a meaningful pattern of treatment choice.…”

Section: Methodsmentioning

confidence: 99%

“…Regarding the correlation analysis, a multiple imputation (MI) using the monotone regression method was applied to adjust for BCVA and CRT at month 12 to eliminate the potential real-world variations in the RENOWNED and REAL studies 28 , 29 .…”

Section: Methodsmentioning

confidence: 99%

“…The data for this retrospective post-hoc study were from two multicenter, open-label, single-arm, observational studies for the use of ranibizumab in nAMD patients (RENOWNED/REAL 28,29 ) and were re-analyzed to explore (1) the proportion of PCV subtypes in Taiwan and (2) to investigate the treatment outcomes of different PCV subtypes. Table 1 shows the demographic data and baseline characteristics of the overall study population, as well as PCV subtypes.…”

mentioning

confidence: 99%

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Comparison of visual outcomes between therapy choices and subtypes of polypoidal choroidal vasculopathy (PCV) in Taiwan: a real-world study

Yeung

Lai

Chen

et al. 2021

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Polypoidal choroidal vasculopathy (PCV) is a distinctive type of neovascular age-related macular degeneration prevalent in many Asian countries. However, there is still some controversy in how the subtypes of PCV are classified. This post-hoc study redefined the branching vascular network (BVN) and PCV subtypes through retrospective review of indocyanine green angiography (ICGA) and fluorescein angiography images from two observational studies (RENOWNED/REAL). Of the visual outcomes for each angiographic subtype and treatment pattern investigated, BVN was identified in 56.3% of PCV patients. The proportions and features of the re-defined PCV subtypes were 43.8%, 10.4%, and 45.8% for subtype A (without distinctive features of BVN), B (with BVN but no leakage), and C (with BVN and leakage), respectively. Subtype A had better visual outcomes when compared to subtype C. This possibly resulted from a better baseline visual acuity in subtype A. Moreover, combination therapy [photodynamic therapy plus anti-vascular endothelial growth factor (VEGF)] may lead to better visual improvement than mono-anti-VEGF treatment alone. This study provides the prevalence of PCV subtypes in Taiwan and may serve as a reference for PCV treatment strategies in a real-world setting, especially for the combination therapy and patients without distinctive features of BVN.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Comparison of visual outcomes between therapy choices and subtypes of polypoidal choroidal vasculopathy (PCV) in Taiwan: a real-world study

Yeung

Lai

Chen

et al. 2021

Sci Rep

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Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy

et al. 2020

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; for the EVEREST II Study Group IMPORTANCE The 2-year efficacy and safety of combination therapy of ranibizumab administered together with verteporfin photodynamic therapy (vPDT) compared with ranibizumab monotherapy in participants with polypoidal choroidal vasculopathy (PCV) are unclear. OBJECTIVE To compare treatment outcomes of ranibizumab, 0.5 mg, plus prompt vPDT combination therapy with ranibizumab, 0.5 mg, monotherapy in participants with PCV for 24 months. DESIGN, SETTING, AND PARTICIPANTS This 24-month, phase IV, double-masked, multicenter, randomized clinical trial (EVEREST II) was conducted among Asian participants from August 7, 2013, to March 2, 2017, with symptomatic macular PCV confirmed using indocyanine green angiography. INTERVENTIONS Participants (N = 322) were randomized 1:1 to ranibizumab, 0.5 mg, plus vPDT (combination therapy group; n = 168) or ranibizumab, 0.5 mg, plus sham PDT (monotherapy group; n = 154). All participants received 3 consecutive monthly ranibizumab injections, followed by a pro re nata regimen. Participants also received vPDT (combination group) or sham PDT (monotherapy group) on day 1, followed by a pro re nata regimen based on the presence of active polypoidal lesions. MAIN OUTCOMES AND MEASURES Evaluation of combination therapy vs monotherapy at 24 months in key clinical outcomes, treatment exposure, and safety. Polypoidal lesion regression was defined as the absence of indocyanine green hyperfluorescence of polypoidal lesions. RESULTS Among 322 participants (mean [SD] age, 68.1 [8.8] years; 225 [69.9%] male), the adjusted mean best-corrected visual acuity (BCVA) gains at month 24 were 9.6 letters in the combination therapy group and 5.5 letters in the monotherapy group (mean difference, 4.1 letters; 95% CI, 1.0-7.2 letters; P = .005), demonstrating that combination therapy was superior to monotherapy by the BCVA change from baseline to month 24. Combination therapy was superior to monotherapy in terms of complete polypoidal lesion regression at month 24 (81 of 143 [56.6%] vs 23 of 86 [26.7%] participants; P < .001). Participants in the combination group received fewer ranibizumab injections (median, 6.0 [interquartile range (IQR), 4.0-11.0]) than the monotherapy group (median, 12.0 [IQR, 7.0-17.0]) up to month 24. The combination group required a median of 2.0 (IQR, 1.0-3.0) vPDT treatments for 24 months, with 75 of 168 participants (44.6%) requiring only 1 vPDT treatment. CONCLUSIONS AND RELEVANCE The 24-month data findings confirm that ranibizumab therapy, given as monotherapy or in combination with vPDT, is efficacious and safe for treatment of PCV. Combination therapy with vPDT added to ranibizumab achieved superior BCVA gain, increased odds of complete polypoidal lesion regression, and fewer treatment episodes compared with ranibizumab monotherapy.

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Systematic review with network meta-analysis of antivascular endothelial growth factor use in managing polypoidal choroidal vasculopathy

Chi

Kang

Huang

2021

Sci Rep

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Polypoidal choroidal vasculopathy (PCV) is a vision-threatening disease common in Asian populations. However, the optimal treatment for PCV remains under debate. We searched the databases with optimal searching strategy. The study included randomized clinical trials and prospective studies that recruited patients with active PCV who had received interventions, including PDT, anti-VEGF, or a combination of PDT and anti-VEGF. The Grading of Recommendations Assessment, Development, and Evaluation methodology was used for rating the quality of evidence. Our study included 11 studies involving 1277 patients. The network meta-analysis of RCTs revealed the anti-VEGF group, early combination group, and late combination group had significant BCVA changes compared with the PDT group. Early combination therapy led to a significant decrease in CRT compared with PDT, anti-VEGF, and late combination therapy. Additionally, the early combination group had a significantly higher complete polyp regression rate than the anti-VEGF group. No significant differences were detected in the analysis of the number of anti-VEGF injections and safety profile. This network meta-analysis revealed that early combination therapy exhibited better efficacy related to anatomical outcomes than other therapies. Nonetheless, no significant differences related to BCVA change could be detected between anti-VEGF and late combination therapy.

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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

Cited by 8 publications

References 26 publications

Comparison of visual outcomes between therapy choices and subtypes of polypoidal choroidal vasculopathy (PCV) in Taiwan: a real-world study

Comparison of visual outcomes between therapy choices and subtypes of polypoidal choroidal vasculopathy (PCV) in Taiwan: a real-world study

Comparison of Ranibizumab With or Without Verteporfin Photodynamic Therapy for Polypoidal Choroidal Vasculopathy

Systematic review with network meta-analysis of antivascular endothelial growth factor use in managing polypoidal choroidal vasculopathy

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