One-Year Outcome of Ranibizumab for Neovascular Age-Related Macular Degeneration: A Thorough Analysis in a Real-World Clinical Setting

Gabai, Andrea; Veritti, Daniele; Lanzetta, Paolo

doi:10.5301/ejo.5000385

Cited by 23 publications

(15 citation statements)

References 16 publications

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“…The CATT 6 and GEFAL 17 considered a difference of five EDTRS letters to represent noninferiority, whereas the MANTA 18 considered a difference of seven letters to be noninferior. 18 Because of the 'ceiling effect', whereby eyes starting treatment with good VA have little room for further improvement, many measures are dependent on the starting VA. 11,12,20 Adjusting for age, starting VA, number of injections, and visits reduced, but did not eliminate the significant variation between centres, suggesting there are other unmeasured factors that contribute to these variations in outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…[10][11][12][13] We have previously reported longitudinal results from a cohort of patients recruited from hospitals in the UK. 10,11,14 Patients had standardised data recorded at the point of care into an electronic medical record (EMR) system, and the grouped national findings showed that PRN retreatment after three loading doses resulted in moderately stable vision.…”

Section: Introductionmentioning

confidence: 99%

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The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

Liew

Lee

Zarranz‐Ventura

et al. 2016

Eye

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Purpose International variations in visual acuity (VA) outcomes of eyes treated for neovascular age-related macular degeneration (nAMD) are well-documented, but intracountry inter-centre regional variations are not known. These data are important for national quality outcome indicators. We aimed to determine intra-country and intercentre regional variations in outcomes for treatment of nAMD. Patients and methods Prospective multicentre national database study of 13 UK centres that treated patients according to a set protocol (three loading doses, followed by Pro-Re-Nata retreatment). A total of 5811 treatment naive eyes of 5205 patients received a total of 36 206 ranibizumab injections over 12 months. Results Mean starting VA between centres varied from 48.9 to 59.9 ETDRS letters. Mean inter-centre VA change from baseline to 12 months varied from +6.9 letters to − 0.6 letters (mean of +2.5 letters). The proportion of eyes achieving VA of 70 letters or more varied between 21.9 and 48.7% at 12 months. Median number of injections (visits) at each centre varied from 5 to 8 (9 to 12), with an overall median of 6 (11). Age, starting VA, number of injections, and visits, but not gender were significantly associated with variation in these VA outcomes (Po0.01). Significant variation between centres persisted even after adjusting for these factors. Conclusion There are modest differences in VA outcomes between centres in the UK. These differences are influenced, but not completely explained, by factors such as patient age, starting VA, number of injections, and visits. These data provide an indication of the VA outcomes that are achievable in real-world settings.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

Liew

Lee

Zarranz‐Ventura

et al. 2016

Eye

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“…29 Two studies reported a decline in visual outcomes with the largest decline in VA of 2.0 letters. 30 In the remaining four studies the VA at study end remained similar to baseline values (−0.8 to 0.97 letters).…”

Section: Change In Vamentioning

confidence: 69%

Ranibizumab for the treatment of wet AMD: a summary of real-world studies

Chong

2015

Eye

111

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Data from real-world studies of ranibizumab in neovascular (wet) age-related macular degeneration suggest that outcomes in clinical practice fail to match those seen in clinical trials. These real-world studies follow treatment regimens that differ from the fixed dosing used in the pivotal clinical trial programme. To better understand the effectiveness of ranibizumab in clinical practice, we conducted a comprehensive evaluation of 12-month outcomes reported in peer-reviewed 'realworld' publications. Key measures included in our analysis were mean change in visual acuity (VA) and the proportion of patients gaining ≥ 15 letters or losing ≤ 15 letters. Twenty studies were eligible for inclusion in our study, with 18 358 eyes having sufficient data for analysis of 12-month outcomes. Mean baseline VA ranged from 48.8 to 61.6 Early Treatment Diabetic Retinopathy Study letters. Mean change in VA was between − 2.0 and +5.5 letters, with a grand mean of +2.9 ± 3.2, and a weighted mean (adjusted for the number of eyes in the study) of +1.95. Eleven studies reported that 19 ± 7.5 (mean value) of patients gained ≥ 15 letters, while in 12 studies the mean percentage of patient losing ≤ 15 letters was 89 ± 6.5%. Our comprehensive analysis of real-world ranibizumab study data confirm that patient outcomes are considerably poorer than those reported in randomised control trials of both fixed and pro re nata regimens.

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“…[19][20][21] This has been previously reported and is attributed to the difficulties in complying with strict follow-up criteria of the trials. 27,28 However, the fundamental aspect of our results was the significant visual acuity gain obtained from phacoemulsification.…”

Section: -11mentioning

confidence: 90%

Safety and Effectiveness of Cataract Surgery with Simultaneous Intravitreal Anti-VEGF in Patients with Previously Treated Exudative Age-Related Macular Degeneration

et al. 2017

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RESUMOIntrodução: Pretendemos avaliar a efectividade e segurança da cirurgia de catarata associada a injecção intravítrea de anti-vascular endothelial growth factor sobre a acuidade visual, morfologia da retina e coróide em doentes previamente tratados por degeneração macular relacionada com a idade exsudativa com cataratas visualmente significativas. Material e Métodos: Estudo prospectivo, que incluiu 21 olhos de 20 doentes com degeneração macular relacionada com a idade exsudativa submetidos a facoemulsificação simultânea com ranibizumab ou bevacizumab intravítreo. Os doentes foram seguidos durante 12 meses após a cirurgia usando uma estratégia pro re nata. As alterações da acuidade visual, espessura da retina e coroideia subfoveal foram avaliadas aos 1, 6 e 12 meses de pós-operatório. Resultados: Houve um aumento estatisticamente significativo da acuidade visual média ao mês (13,4 letras, p < 0,05), aos seis (11,5 letras, p < 0,05) e doze meses (11,3 letras, p < 0,05), sem alterações significativas na morfologia da retina ou coróide. Aos 12 meses, 86% dos olhos foram capazes de manter a melhoria da acuidade visual. Não houve diferenças significativas entre os dois fármacos anti-vascular endothelial growth factor e não ocorreu qualquer complicação durante o seguimento. Discussão: A facoemulsificação associada a injecção intravítrea de anti-vascular endothelial growth factor é segura e permite uma melhoria da acuidade visual em doentes com degeneração macular relacionada com a idade exsudativa e cataratas visualmente significativas. O ganho de acuidade visual foi mantido usando uma estratégia pro re nata mostrando que neste subgrupo de doentes a facoemulsificação pode ser benéfica. Conclusão: A cirurgia de catarata associada a terapia anti-vascular endothelial growth factor simultânea melhora a acuidade visual em doentes com degenerescência macular da idade exsudativa. Palavras-chave: Degeneração Macular; Extração de Catarata; Facoemulsificação; Factores de Crescimento do Endotélio Vascular; Neovascularização; Resultado do Tratamento ABSTRACT Introduction: To evaluate the safety and impact on visual acuity, retinal and choroidal morphology of simultaneous cataract surgery and intravitreal anti-vascular endothelial growth factor on patients with visually significant cataracts and previously treated exudative age-related macular degeneration. Material and Methods:Prospective study, which included 21 eyes of 20 patients with exudative age-related macular degeneration submitted to simultaneous phacoemulsification and intravitreal ranibizumab or bevacizumab. The patients were followed for 12 months after surgery using a pro re nata strategy. Visual acuity, foveal and choroidal thickness changes were evaluated 1, 6 and 12 months post-operatively.Results: There was a statistically significant increase in mean visual acuity at one (13.4 letters, p < 0.05), six (11.5 letters, p < 0.05) and twelve months (11.3 letters, p < 0.05) without significant changes in retinal or choroidal morphology. At 12 months, 86% of eyes wer...

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One-Year Outcome of Ranibizumab for Neovascular Age-Related Macular Degeneration: A Thorough Analysis in a Real-World Clinical Setting

Abstract: Our results compare unfavorably with those of controlled trials. Treatment and follow-up regimens in real-world settings seem to have a major role in determining outcome. Lower age and BCVA at baseline were associated with better response to treatment.

Cited by 23 publications

References 16 publications

The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

Ranibizumab for the treatment of wet AMD: a summary of real-world studies

Safety and Effectiveness of Cataract Surgery with Simultaneous Intravitreal Anti-VEGF in Patients with Previously Treated Exudative Age-Related Macular Degeneration

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