Real‐world visual outcomes in patients with neovascular age‐related macular degeneration receiving aflibercept at fixed intervals as per UK licence

Öztürk, Mehmet; Harris, M. L.; Nguyen, Vuong; Barthelmes, Daniel; Gillies, Mark C; Mehta, Hemal

doi:10.1111/ceo.13085

Cited by 28 publications

(31 citation statements)

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“…Aflibercept has also been evaluated with several treatment regimens. 8 , 23 , 24 In the VIEW studies, monthly and bimonthly aflibercept treatment after 3 loading doses resulted in 8-9 letters of visual increase at month 12. 8 Yamamoto et al 25 evaluated the efficacy of treat-and-extend regimen with aflibercept in nAMD and demonstrated 1.5 lines of visual increase at month 12.…”

Section: Discussionmentioning

confidence: 99%

“…In all of these and other randomized controlled studies, the mean injection number during the first year was reported as at least 8. 6 , 8 , 12 , 23 , 24 , 25 On the other hand, reaching this injection number seems nearly impossible with the PRN treatment regimen in real life. 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 Most of the retrospective real-life studies reported the injection number as 3-4 during the first year.…”

Section: Discussionmentioning

confidence: 99%

“…After proving this fact, the performance of other treatment regimens was evaluated or compared with PRN regimen in new studies. 9 , 10 , 23 Ozturk et al 23 retrospectively evaluated the outcomes of fixed bimonthly injection of aflibercept. They reported that 50% of the patients received the 8 obligatory injections during 12 months, and only 2 of the 42 patients were reported to receive 5 injections, which was the minimum injection number among the study patients.…”

Section: Discussionmentioning

confidence: 99%

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Real-World Outcomes of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration in Turkey: A Multicenter Retrospective Study, Bosphorus Retina Study Group Report No: 1

Özkaya

Karabaş

Alagöz

et al. 2018

tjo

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Objectives:To evaluate the real-world outcomes of intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment in neovascular age-related macular degeneration (nAMD) patients.Materials and Methods:Multicenter, retrospective, interventional, non-comparative study. The records of nAMD patients treated with an anti-VEGF agent on a pro re nata treatment regimen basis between January 2013 and December 2015 were reviewed. The patients who completed a follow-up period of 12 months were included. Primary outcome measures of this study were the visit and injection numbers during the first year.Results:Eight hundred eighty eyes of 783 patients met the inclusion criteria for the study. Mean number of visits at month 12 was 6.9±2.5 (range: 1-15). Mean number of injections at month 12 was 4.1±1.9 (range: 1-11). Mean visual acuity at baseline and months 3, 6, and 12 was 0.90±0.63 LogMAR (range: 0.0-3.0), 0.79±0.57 LogMAR (range: 0.0-3.0), 0.76±0.57 LogMAR (range: 0.0-3.0), and 0.79±0.59 LogMAR (range: 0.0-3.0), respectively. Mean central retinal thickness at baseline and months 6 and 12 was 395±153 μm (range: 91-1582), 330±115 μm (range: 99-975), and 332±114 μm (range: 106-1191), respectively.Conclusion:The numbers of visits and injections were much lower than ideal and were insufficient with the pro re nata treatment regimen.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Real-World Outcomes of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration in Turkey: A Multicenter Retrospective Study, Bosphorus Retina Study Group Report No: 1

Özkaya

Karabaş

Alagöz

et al. 2018

tjo

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“…The advent of electronic medical records (EMR) has facilitated the collection of large amounts of data in routine clinical practice and thus has the potential to make retrospective study populations more representative of real life. (13)(14)(15)(16)(17)(18) were merged into the current centralised repository, the data warehouse. We have created a dataset from this which represents, to our knowledge, the largest single-center cohort of patients receiving treatment for neovascular AMD in the world.…”

Section: Introductionmentioning

confidence: 99%

“…The advent of electronic medical records (EMR) has facilitated the collection of large amounts of data in routine clinical practice and thus has the potential to make retrospective study populations more representative of real life. (13)(14)(15)(16)(17)(18) This is very much dependent, however, on the quality of data entry and the reliable follow-up of patients, and so these issues can remain problematic. The amount of data available from EMR systems also challenges the traditional methods of validation, analytics and reporting, and there is a struggle to implement the existing clinical research guidelines.…”

Section: Introductionmentioning

confidence: 99%

One and Two Year Visual Outcomes from the Moorfields AMD Database - an Open Science Resource for the Study of Neovascular Age-related Macular Degeneration

Fasler

Moraes

Wagner

et al. 2018

Preprint

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ObjectivesTo analyse treatment outcomes and share clinical data from a large, single-center, well-curated database (8174 eyes / 6664 patients with 120,756 single entries) of patients with neovascular age related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (VEGF). By making our depersonalised raw data openly available, we aim to stimulate further research in AMD, as well as setting a precedent for future work in this area.SettingRetrospective, comparative, non-randomised electronic medical record (EMR) database cohort study of the UK Moorfields AMD database with data extracted between 2008 and 2018.Participants3357 eyes/patients (61% female). Extraction criteria were ≥ 1 ranibizumab or aflibercept injection, entry of “AMD” in the diagnosis field of the EMR, and a minimum of one year of follow-up. Exclusion criteria were unknown date of first injection and treatment outside of routine clinical care at Moorfields before the first recorded injection in the database.Main outcome measuresPrimary outcome measure was change in VA at one and two years from baseline as measured in Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Secondary outcomes were the number of injections and predictive factors for VA gain.ResultsMean VA gain at one-year and two years were +5.5±0.5 and +4.9±0.68 letters respectively. Fifty-four percent of eyes gained ≥5 letters at two years, 63% had stable VA (±≤14 letters), forty-four percent of eyes maintained good VA (≥70 letters). Patients received a mean of 7.7±0.06 injections during year one and 13.0±0.2 injections over two years.Younger age, lower baseline VA, and more injections were associated with higher VA gain at two years.ConclusionThis study benchmarks high quality EMR study results of real life AMD treatment and promotes open science in clinical AMD research by making the underlying data publicly available.Strengths and limitations of this study-Large sample size, retrospective, single centre, electronic medical record database study-High quality real life data-Open science approach with sharing of depersonalised raw data

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Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration

et al. 2020

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IMPORTANCE Faricimab neutralizes angiopoietin-2 and vascular endothelial growth factor A via both simultaneous and independent binding. OBJECTIVE To evaluate extended dosing with faricimab, the first bispecific antibody designed for intraocular use, in patients with neovascular age-related macular degeneration. DESIGN, SETTING, AND PARTICIPANTSThis phase 2 randomized clinical trial was a 52-week multicenter, active comparator-controlled, parallel-group study. Study participants were enrolled in 25 sites in the US from January and March 2017 with treatment-naive choroidal neovascularization secondary to neovascular age-related macular degeneration and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study letter score of 73 (approximate Snellen equivalent, 20/40) to 24 (approximate Snellen equivalent, 20/320). Analysis began January 2017 and ended March 2018.INTERVENTIONS Participants were randomized 1:2:2 to receive intravitreal ranibizumab, 0.5 mg, every 4 weeks or faricimab, 6.0 mg, every 12 or 16 weeks. Participants in the faricimab arms initially received 4 monthly injections of faricimab. No rescue injections were allowed. Participants randomized to dosing every 16 weeks were assessed for disease activity at week 24 using prespecified criteria. Those with no active disease continued dosing every 16 weeks through trial end; participants with disease activity continued received dosing every 12 weeks. MAIN OUTCOMES AND MEASURESMean change in BCVA from baseline at week 40. RESULTSOf 76 participants enrolled (mean [SD] age, 78.5 [8.5] years; age range, 56-94 years; 41 women [58%]; 69 white [97%]), 16 (21.0%) were randomized to ranibizumab every 4 weeks, 29 (38.2%) to faricimab every 12 weeks, and 31 (40.8%) to faricimab every 16 weeks. At week 24, 12 weeks after their last initiation injection, 65% (36 of 55) of all faricimab-treated participants had no disease activity. At week 40, adjusted mean BCVA gains from baseline (Early Treatment Diabetic Retinopathy Study letters) were +11.4 (80% CI, 7.8-15.0), +9.3 (80% CI, 6.4-12.3), and +12.5 (80% CI, 9.9-15.1) for the ranibizumab every 4 weeks, faricimab every 12 weeks, and faricimab every 16 weeks arms, respectively. Participants received a mean (SD) total of 12.9 (0.25), 6.7 (0.91), and 6.2 (0.93) injections, for the ranibizumab every 4 weeks, faricimab every 12 weeks, and faricimab every 16 weeks arms, respectively, through week 52. The secondary BCVA and anatomical imaging end points supported the primary end point and were comparable with ranibizumab every 4 weeks. No new or unexpected safety signals were identified.CONCLUSIONS AND RELEVANCE At week 52, faricimab dosing every 16 weeks and every 12 weeks resulted in maintenance of initial vision and anatomic improvements comparable with monthly ranibizumab. These results suggest a role for simultaneous neutralization of angiopoietin-2 and vascular endothelial growth factor A in providing sustained efficacy through extended durability, warranting further investigation.TRIAL REGISTRATION Cli...

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Real‐world visual outcomes in patients with neovascular age‐related macular degeneration receiving aflibercept at fixed intervals as per UK licence

Cited by 28 publications

References 12 publications

Real-World Outcomes of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration in Turkey: A Multicenter Retrospective Study, Bosphorus Retina Study Group Report No: 1

Real-World Outcomes of Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration in Turkey: A Multicenter Retrospective Study, Bosphorus Retina Study Group Report No: 1

One and Two Year Visual Outcomes from the Moorfields AMD Database - an Open Science Resource for the Study of Neovascular Age-related Macular Degeneration

Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration

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