SIERRA-AMD: A Retrospective, Real-World Evidence Study of Patients with Neovascular Age-Related Macular Degeneration in the United States

Khanani, Arshad M.; Skelly, A; Bezlyak, Vladimir; Griner, Raymond; Torres, Laura Rodriguez; Sagkriotis, Alexandros

doi:10.1016/j.oret.2019.09.009

Cited by 59 publications

(38 citation statements)

References 34 publications

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“…This highlights poor compliance of patients returning to the clinic for follow-up, likely due to high treatment burden (12) or patient relocation and transfer to another healthcare facility. The high discontinuation rate was expected, and was aligned with real-world trends in Korea, that have also been reported in other real-world studies (13,14). In the current study, 28.9% of patients switched to anti-VEGFs other than ranibizumab, and the majority were prior-treated.…”

Section: Discussionsupporting

confidence: 88%

Real-world effectiveness, treatment pattern, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration: Subgroup analyses from the LUMINOUS study

Sagong

Woo

Lee

2020

Preprint

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Background To evaluate the real-world effectiveness, treatment patterns, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration (nAMD). Methods LUMINOUS™ is a 5-year, global, prospective, observational, open-label study. Adults aged ≥18 years who were either treatment-naïve or prior-treated were enrolled and treated with ranibizumab 0.5 mg per the local label. Outcome measures included mean (±standard deviation) changes from baseline in visual acuity (VA) and central retinal thickness (CRT), and rate of ocular and non-ocular adverse events (AEs). Results Overall, 367 Korean patients with nAMD (152 treatment-naïve and 215 prior-treated) were enrolled. The mean VA changes from baseline at 1-year were +10.1 (±21.77; P = 0.0005) and +1.4 (±15.17; P = 0.2142) Early Treatment Diabetic Retinopathy Study letters, with mean number of injections of 5.2 and 3.4 in the treatment-naïve and prior-treated groups, respectively. VA gains were greater in patients with worse baseline VA, who received a loading dose, and with polypoidal choroidal vasculopathy (PCV). Multivariate logistic regression analyses demonstrated younger age, worse baseline VA, and those who received loading dose being associated with higher odds of any gain in VA at 1 year ( P < 0.05). Mean CRT changes from baseline were –126.7 (±174.90) µm ( P < 0.0001) and +10.8 (±89.52) µm ( P = 0.5833) in the treatment-naïve and prior-treated groups, respectively, with greater reductions observed in patients with PCV. Ocular and non-ocular AEs were reported in 8.4% (n=31) and 10.1% (n=37) of patients, respectively. Conclusion The LUMINOUS study confirms real-world effectiveness and safety of ranibizumab in Korean patients with nAMD; factors including age, baseline VA, and loading-dose were associated with VA gain at one-year post-treatment.

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Section: Discussionsupporting

confidence: 88%

Real-world effectiveness, treatment pattern, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration: Subgroup analyses from the LUMINOUS study

Sagong

Woo

Lee

2020

Preprint

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“…registry with mixed treatment and the T&E regimen (+ 5.3 letters at 2 years) showed better results with higher mean yearly injections 19 , 35 . The 3- and 4-year outcomes of our study (− 1.3 [RBZ] vs. − 1.8 [AFL] letters at 3 years, − 2.2 [RBZ] vs. − 5.0 [AFL] letters at 4 years, p > 0.05) showed comparable results with the study using anonymized US EMR data with mixed treatment (− 3.1 letters at 3 years and − 5.2 letters at 4 years) 33 . However, a recent study with FRB!…”

Section: Discussionsupporting

confidence: 77%

Long-term outcomes of ranibizumab vs. aflibercept for neovascular age-related macular degeneration and polypoidal choroidal vasculopathy

Jin

Kim

Park

et al. 2021

Sci Rep

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To evaluate the long-term outcomes of ranibizumab (RBZ) vs. aflibercept (AFL) in treatment-naïve eyes with typical neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV). This multicenter, retrospective, matched-cohort analysis was conducted on data up to 4 years of follow-ups. The primary outcome was the visual acuity (VA) change from baseline. The secondary outcomes included the number of injections, proportion of eyes without a yearly injection, and the number of eyes with treatment switching. Subgroup analyses were performed for typical nAMD and PCV. Typical nAMD was defined as nAMD other than PCV. We included VA-matched 215 eyes of 209 patients (131 and 84 eyes with RBZ and AFL, respectively). The crude mean VA changes from baseline were + 6.7 vs. + 2.6, + 2.1 vs. − 0.4, − 1.3 vs. − 1.8, and − 2.2 vs. − 5.0 letters in the RBZ and AFL groups, at 1, 2, 3, and 4 years, respectively (p > 0.05). The adjusted predicted VA by linear mixed model, proportion of eyes stratified by VA, and the survival curve for significant vision loss were comparable during the 4-year follow-up (p > 0.05). The mean number of injections were similar between the RBZ and AFL groups (2.9 vs. 3.0, respectively, p = 0.692). The subgroup analysis for typical nAMD and PCV showed similar results between the groups. The visual outcomes did not differ between RBZ and AFL during 4 years with comparable numbers of injections. Our study reflects the long-term, real-world clinical practice and treatment pattern of two treatments for typical nAMD and PCV.

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“…The high discontinuation rate was expected, and aligned with real-world trends in Korea, that have also been reported in other real-world studies. 13,14 In the current study, 28.9% of patients switched to anti-VEGFs other than ranibizumab, and the majority were prior-treated. The 2019 Preferences and Trends Survey showed that 68.4% of Asia Pacific physicians would switch to another anti-VEGF when patients do not respond adequately to firstline anti-VEGF therapy.…”

Section: Discussionmentioning

confidence: 67%

Real-World Effectiveness, Treatment Pattern, and Safety of Ranibizumab in Korean Patients with Neovascular Age-Related Macular Degeneration: Subgroup Analyses from the LUMINOUS Study

Sagong¹,

Woo²,

Lee³

2021

OPTH

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Purpose: To evaluate the real-world effectiveness, treatment patterns, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration (nAMD). Methods: LUMINOUS™ is a 5-year, global, prospective, observational, open-label study. Adults aged ≥18 years who were either treatment-naïve or prior-treated were enrolled and treated with ranibizumab 0.5 mg as per the local label. Outcome measures included mean (± standard deviation [SD]) changes from baseline in visual acuity (VA) and central retinal thickness (CRT), and rate of ocular and non-ocular adverse events (AEs). Results: Overall, 367 Korean patients with nAMD (152 treatment-naïve and 215 priortreated) were enrolled. The mean (SD) VA changes from baseline at 1-year were +10.1 (±21.77; P=0.0005) and +1.4 (±15.17; P=0.2142) Early Treatment Diabetic Retinopathy Study letters, with mean numbers of injections of 5.2 and 3.4 in the treatment-naïve and prior-treated groups, respectively. VA gains were greater in patients with lower baseline VA, who received a loading dose, and with polypoidal choroidal vasculopathy (PCV). Multivariate logistic regression analyses demonstrated younger age, worse baseline VA, and those who received loading dose being associated with higher odds of any gain in VA at 1 year (P<0.05). Mean (SD) CRT changes from baseline were -126.7 (±174.90) µm (P<0.0001) and +10.8 (±89.62) µm (P=0.5833) in the treatment-naïve and prior-treated groups, respectively, with greater reductions observed in patients with PCV. Ocular and nonocular AEs were reported in 8.4% (n=31) and 10.1% (n=37) of patients, respectively. Conclusion:The LUMINOUS study confirms real-world effectiveness and safety of ranibizumab in Korean patients with nAMD; factors including age, baseline VA, and loadingdose were associated with VA gain at one-year post-treatment.

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SIERRA-AMD: A Retrospective, Real-World Evidence Study of Patients with Neovascular Age-Related Macular Degeneration in the United States

Cited by 59 publications

References 34 publications

Real-world effectiveness, treatment pattern, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration: Subgroup analyses from the LUMINOUS study

Real-world effectiveness, treatment pattern, and safety of ranibizumab in Korean patients with neovascular age-related macular degeneration: Subgroup analyses from the LUMINOUS study

Long-term outcomes of ranibizumab vs. aflibercept for neovascular age-related macular degeneration and polypoidal choroidal vasculopathy

Real-World Effectiveness, Treatment Pattern, and Safety of Ranibizumab in Korean Patients with Neovascular Age-Related Macular Degeneration: Subgroup Analyses from the LUMINOUS Study

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