Six-year outcomes in neovascular age-related macular degeneration with ranibizumab

Jacob, Julie A.; Brié, Heidi; Leys, Anita; Mergaerts, Filip; Denhaerynck, Kris; Vancayzeele, Stefaan; Craeyveld, Eline Van; Abraham, Ivo; MacDonald, Karen

doi:10.18240/ijo.2017.01.14

Cited by 19 publications

(20 citation statements)

References 38 publications

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“…The outcomes for the treatment-naïve eyes were largely consistent with data from previous longer-term realworld studies of ranibizumab, [13][14][15][16][17][18][19] including two Belgian studies reporting on 2-year and 6-year outcomes. 13,14 Although variability was detected in the VA and CRT values, overall, a generally well-preserved mean VA was observed, with an initial gain that was gradually lost over time (−1.8 letters/year). Anatomically, a sustained decrease in mean CRT was recorded to study end.…”

Section: Discussionsupporting

confidence: 81%

“…While the efficacy and safety profile of ranibizumab use in nAMD is well established based on clinical trial evidence, [9][10][11][12] most evaluations of the longerterm (≥2 years) effectiveness and safety of ranibizumab in routine clinical practice have been limited-sample studies in one or a few countries. [13][14][15][16][17][18][19] In addition, treatment patterns of ranibizumab have not been extensively investigated in a realworld setting.…”

Section: Introductionmentioning

confidence: 99%

“…Being the largest prospective observational trial in the medical retina field, this study recruited 30,138 patients from 488 sites in 42 countries. 20 We have previously reported on the 2-year 13 and 6year 14 outcomes of treatment with ranibizumab for nAMD as observed in routine clinical practice in Belgium. Here, we assessed treatment patterns and associated outcomes in patients with nAMD of the Belgian (BE) cohort from the global LUMINOUS study, thus adding to the evidence base of real-world effectiveness and safety of ranibizumab use in Belgium.…”

Section: Introductionmentioning

confidence: 99%

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<p>Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study</p>

Leys¹,

Ramboer²,

Favreau³

et al. 2020

OPTH

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Purpose: To evaluate long-term, real-world treatment patterns and outcomes of ranibizumab 0.5 mg for neovascular age-related macular degeneration (nAMD) in a Belgian cohort. Patients and Methods: This Belgian (BE) cohort of the 5-year global observational LUMINOUS study included 229 patients with nAMD. Outcomes included visual acuity (VA), central retinal thickness (CRT) and safety. Results: The mean age was 79.5±7.7 years. The majority of patients (67.7%) were female and all patients were Caucasian. Most patients previously received ranibizumab with only 17.5% of patients being treatment-naïve. The injection frequency declined over time irrespective of prior treatment status (p<0.0001), with treatment-naïve eyes receiving a mean of 4.2±2.9 yearly injections and prior-ranibizumab eyes 3.6±2.7. Regression analysis confirmed first-year VA increases for treatment-naïve eyes (p=0.002) followed by a slight decrease of −1.8 letters per year. For prior-ranibizumab eyes, the visual changes over 1 year were statistically non-significant (p=0.90) but declined slightly after year one (p<0.0001). Anatomically, the CRT of treatment-naïve eyes decreased over time from baseline (p<0.0001), whereas the CRT of prior-ranibizumab eyes remained stable (p=0.43). No new safety findings were identified. Conclusion: LUMINOUS-BE reconfirms the well-characterized benefit-risk profile of ranibizumab for nAMD treatment. The observed low injection frequency reflects a need for more rigorous treatment in real-world settings. Clinical Trial Registration: NCT01318941.

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Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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<p>Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study</p>

Leys¹,

Ramboer²,

Favreau³

et al. 2020

OPTH

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“…[19] More than half of our cohort were followed-up after 10 years (54%) and approximately half of these were still receiving treatment. This rate of attendance is greater than those reported in other RCTs and real-life studies, [9,10,[20][21][22][23][24] with death being the main cause of LTFU. First-affected eyes received a mean 37.04 ± 24.19 injections over the whole observation period, comparably to a recent report on 10-year outcomes of a Swiss cohort.…”

Section: Discussioncontrasting

confidence: 55%

Ten-year survival trends of neovascular age-related macular degeneration at first presentation

et al. 2020

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BackgroundTo describe 10-year trends in visual outcomes, anatomical outcomes and treatment burden of patients receiving antivascular endothelial growth factor (anti-VEGF) therapy for neovascular age-related macular degeneration (nAMD).MethodsRetrospective cohort study of treatment-naïve, first-affected eyes with nAMD started on ranibizumab before January 1, 2009. The primary outcome was time to best-corrected visual acuity (BCVA) falling ≤35 ETDRS letters after initiating anti-VEGF therapy. Secondary outcomes included time to BCVA reaching ≥70 letters, proportion of eyes with BCVA ≥70 and ≤35 letters in 10 years, mean trend of BCVA and central retinal thickness over 10 years, and mean number of injections.ResultsFor our cohort of 103 patients, Kaplan-Meier analyses demonstrated median time to BCVA reaching ≤35 and ≥70 letters were 37.8 (95% CI 22.2 to 65.1) and 8.3 (95% CI 4.8 to 20.9) months after commencing anti-VEGF therapy, respectively. At the final follow-up, BCVA was ≤35 letters and ≥70 letters in 41.1% and 21%, respectively, in first-affected eyes, while this was the case for 5.4% and 48.2%, respectively, in a patient’s better-seeing eye. Mean injection number was 37.0±24.2 per eye and 53.6±30.1 at patient level (63.1% of patients required injections in both eyes).ConclusionsThe chronicity of nAMD disease and its management highlights the importance of long-term visual prognosis. Our analyses suggest that one in five patients will retain good vision (BCVA ≥70 ETDRS letters) in the first-affected eye at 10 years after starting anti-VEGF treatment; yet, one in two patients will have good vision in their better-seeing eye. Moreover, our data suggest that early treatment of nAMD is associated with better visual outcomes.

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“…Несмотря на значительный прогресс в лечении неоваскулярной формы ВМД, многие пациенты нуждаются в повторных частых введениях препаратов и длительном регулярном наблюдении. В многоцентровом клиническом исследовании SEVEN-UP показано, что средняя острота зрения пациентов, выбывших из исследований MARINA и ANCHOR и получавших повторное лечение по мере необходимости, последовательно снижалась [39]. Эти данные указывают на обоснованность терминов «рефрактерная неоваскулярная ВМД» и «рецидивирующая неоваскулярная ВМД».…”

Section: последовательная активация системы комплемента и воспалительunclassified

Pharmacological Analysis of Resistance to Anti-VEGF Therapy

Будзинская¹,

Плюхова²,

Andreeva³

et al. 2019

Oftalʹmologiâ

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Age-related macular degeneration (AMD) is a disease that occurs in adults over 50 years old and the leading cause of irreversible blindness in developed countries. AMD is characterized with a lesion of retina macular area and leads to a deterioration in central vision. Therapy aimed at combating the vascular endothelial growth factor (VEGF) resulted in an increase of corrected visual acuity in patients with neovascular age-related macular degeneration. Possible significant differences in the response to anti-VEGF therapy are due to the existence of several anti-VEGF agents with different molecular configurations. Currently, there is no consensus on classification of the optimal response or its absence with this method of treatment. In particular, there is confusion about such terms as “defendant status” after treatment with n-AMD, “tachyphylaxis” and “resistant” n-AMD. Drug tolerance is a pharmacological concept applicable to a patient’s response to a particular drug, with the physiological drug concentration is reducing in case of re-introduced. It requires the increasement the dose or frequency of drug administration to achieve the desired therapeutic effect. Tachyphylaxis is a term indicating a sudden decrease in response to a drug after its administration. This process can develop both after the initial or several administration in small doses. Tachyphylaxis develops in the background or after treatment with ranibizumab with at least two injections of the drug.Switching the treatment regimen to aflibercept or conbercept can be effective in patients resistant to bevascizumab or ranibizumab.The involvement of other pathological processes in the development mechanism of the neovascular form of AMD in addition to increased expression of VEGF dictates the need for combined therapy for this group of patients.

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Six-year outcomes in neovascular age-related macular degeneration with ranibizumab

Cited by 19 publications

References 38 publications

<p>Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study</p>

<p>Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study</p>

Ten-year survival trends of neovascular age-related macular degeneration at first presentation

Pharmacological Analysis of Resistance to Anti-VEGF Therapy

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