Information Used to Decide on Retreatment of Exudative Age-Related Macular Degeneration with anti-VEGF in Clinical Practice

2013 ◽  
Vol 23 (1) ◽  
pp. 108-113 ◽  
Author(s):  
Kleanthis Manousaridis ◽  
Vina Manjunath ◽  
James Talks
Keyword(s):  
Clinical Practice ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Anti Vegf ◽  
Age Related

scholarly journals Anti-VEGF therapy of neovascular age-related macular degeneration: from randomized trials to routine clinical practice

2019 ◽  
Vol 12 (2) ◽  
pp. 97-105 ◽  
Author(s):  
R. R. Fayzrakhmanov
Keyword(s):  
Clinical Practice ◽  
Macular Degeneration ◽  
Randomized Clinical Trials ◽  
High Reliability ◽  
Functional Results ◽  
Routine Clinical Practice ◽  
Age Related Macular Degeneration ◽  
Treatment Protocols ◽  
Anti Vegf ◽  
Age Related

Antivasoproliferative therapy is a revolutionary trend in the treatment of neovascular age-related macular degeneration (nAMD), as it is aimed at blocking growth factors of the newly formed vessels. Currently, two anti-VEGF drugs are registered for ophthalmological use, and the search for new molecules is only gaining momentum. Studying new approaches to treatment and developing innovative drugs, modern medicine relies on the data from international randomized clinical trials (RCT). The fact that this direction attracts much scientific interest is explained by high reliability of the data obtained with RCTs. However, when analyzing the effectiveness of anti-VEGF therapy in patients with nAMD in routine clinical practice, many ophthalmologists are confronted with discrepancies between the expected morphological and functional results as predicted by RCTs and those obtained in reality. It is thus important to bear in mind that RCTs simply determine how the dynamics of morphofunctional parameters should look like, whilst the ideal result is only achievable through correct implementation of therapeutic strategy in real clinical practice. The results obtained in the practice of any specialist wholly depend on how carefully the prescribed treatment protocols are followed by doctors and patients, how burdensome the treatment is, as well as on the potential of the medication. This literary review offers a comparative analysis of the results achieved by using anti-VEGF drugs (ranibizumab and aflibercept) obtained in key RCTs and in routine clinical treatment of nAMD patients.

Visual Acuity Outcomes in Patients Receiving Frequent Treatment of Neovascular Age-Related Macular Degeneration in Clinical Practice

2020 ◽  
pp. 247412642096089
Author(s):  
Andrew A. Moshfeghi ◽  
John D. Pitcher ◽  
Genevieve Lucas ◽  
Nick Boucher ◽  
Namrata Saroj
Keyword(s):  
Visual Acuity ◽  
Clinical Practice ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
First Year ◽  
Treatment Frequency ◽  
Anti Vegf ◽  
Age Related ◽  
Endothelial Growth Factor ◽  
Change In Mean

Purpose: This work evaluates dosing frequency with intravitreal antivascular endothelial growth factor (anti-VEGF) agents over 2 years and visual acuity (VA) outcomes in neovascular age-related macular degeneration (nAMD). Methods: This retrospective analysis assesses electronic medical record data (Vestrum Health treatment and outcomes database) of newly diagnosed nAMD in patients who were initiated on intravitreal anti-VEGF treatment at US clinical sites. Eyes were divided into 2 injection frequency subcohorts (≤ 6 or > 6 injections/y); treatment frequency and change in mean VA (Early Treatment Diabetic Retinopathy Study letters) were evaluated. Results: Overall, 8127 of 213 824 eyes met inclusion criteria in year 1 and 4968 in year 2. During year 1, 77% of the eyes received more than 6 injections (n = 6287), the majority of which received injections at the same frequency during year 2. Mean VA gain from baseline at year 1 was lower in the ≤ 6 than > 6 injections/y subcohort (2.2 vs 6.5, P < .001). Decrease in mean VA from the end of year 1 to year 2 was significantly greater for eyes administered 6 or fewer injections in year 2 than those that received more frequent injections, irrespective of the frequency of injections in the first year. Conclusions: In routine clinical practice, most eyes with nAMD that completed at least 1 year of follow-up were treated with more than 6 injections of anti-VEGF agents during the first year of treatment, resulting in better VA gains than eyes treated less frequently during the same period.

scholarly journals Endpoints selection in registration clinical trials and the needs of real-world clinical practice with the example of anti-VEGF therapy in neovascular age-related macular degeneration

2021 ◽  
Vol 14 (1) ◽  
pp. 25-33
Author(s):  
Sergey Yu. Astakhov ◽  
Svyatoslav L. Plavinskii
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Macular Degeneration ◽  
Real World ◽  
New Technologies ◽  
Age Related Macular Degeneration ◽  
Type I ◽  
Regulatory Requirements ◽  
Anti Vegf ◽  
Age Related

The issues of endpoints selection for regulatory requirements and real-world clinical practice using the example of anti-VEGF therapy in neovascular age-related macular degeneration (nAMD) are discussed in the article. New technologies (optical coherent tomography) introduction are shown to change clinical practice but not regulatory requirements on the endpoints. In the same time for regulatory purpose clinical trials design is changed from superiority to non-inferiority. The changes in the approach to primary endpoint selection are not anticipated due to regulators conservatism but there is a requirement to the comparison with best treatment alternative (i.e. same class comparator in case of anti-VEGF therapy) due to ethical reasons. To satisfy real-world clinicians need, the secondary endpoints are analyzed, but multiple testing problem appears. Statistical methods developed in recent years allow using specified comparison to be made without inflating Type I error. HAWK and HARRIER clinical trials demonstrated an example how superiority of brolucizumab over aflibercet on anatomical endpoints was reliably found.

scholarly journals Economic burden of age-related macular degeneration in routine clinical practice: the RAMDEBURS study

2021 ◽  
Author(s):  
José M. Ruiz-Moreno ◽  
Luís Arias ◽  
Maximino J. Abraldes ◽  
Javier Montero ◽  
Patricia Udaondo ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Macular Degeneration ◽  
Healthcare Costs ◽  
Routine Clinical Practice ◽  
Age Related Macular Degeneration ◽  
Hospital Perspective ◽  
Anti Vegf ◽  
Age Related ◽  
Patients Experience ◽  
Mean Cost

Abstract Purpose To describe and evaluate the main direct health costs, in routine clinical practice, of age-related macular degeneration (AMD) patients, from hospital perspective, in Spain. Methods Retrospective, multicenter, and observational study conducted on five third-level Spanish hospitals, between December 2018 and December 2019. The study included patients who were diagnosed of AMD before December 2018. Direct healthcare costs were obtained from a Spanish database. Study variables included demographic and clinical variables, and resources, such as treatment, diagnostic tests, medical examination, and surgery. Among the 1414 screened AMD patients, 1164 patients were included. In the overall study patients, the total cost was €5,386,511.0, with a mean cost per patient of €4627.6 ± 2383.9. The largest cost items were diagnostic examinations (€2.832.902,0) and vascular endothelial growth factor inhibitors (anti-VEGF) treatment (€2.038.257,2). Bevacizumab was administered to 325 (27.9%) patients, ranibizumab to 328 (28.2%), and aflibercept to 626 (53.8%); 115 (10.7%) patients received two anti-VEGF treatments, while 90 (7.7%) did not receive any. Over the course of the study, a total of 6,057 anti-VEGF injections were administered, with a mean (95% confidence interval) of 4.8 (4.4–5.2) injections per patient. Regarding safety, 29 patients experience injection-related adverse events, among them 12 patients had cataract and 11 ones elevated intraocular pressure (IOP). The incidence of endophthalmitis was 0.5% (6/1164). Conclusions AMD was associated with considerable healthcare costs for regional healthcare systems. Diagnostic examinations, particularly OCT examinations, and anti-VEGF treatment represented the largest cost items.

scholarly journals Genetic biomarkers in the VEGF pathway predicting response to anti-VEGF therapy in age-related macular degeneration

2019 ◽  
Vol 4 (1) ◽  
pp. e000273
Author(s):  
Irina Balikova ◽  
Laurence Postelmans ◽  
Brigitte Pasteels ◽  
Pascale Coquelet ◽  
Janet Catherine ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Treatment Response ◽  
Multiple Testing ◽  
Age Related Macular Degeneration ◽  
Patient Specific ◽  
Multiple Testing Correction ◽  
Anti Vegf ◽  
Age Related ◽  
Vegf Pathway

ObjectiveAge-related macular degeneration (ARMD) is a leading cause of visual impairment. Intravitreal injections of anti-vascular endothelial growth factor (VEGF) are the standard treatment for wet ARMD. There is however, variability in patient responses, suggesting patient-specific factors influencing drug efficacy. We tested whether single nucleotide polymorphisms (SNPs) in genes encoding VEGF pathway members contribute to therapy response.Methods and analysisA retrospective cohort of 281 European wet ARMD patients treated with anti-VEGF was genotyped for 138 tagging SNPs in the VEGF pathway. Per patient, we collected best corrected visual acuity at baseline, after three loading injections and at 12 months. We also registered the injection number and changes in retinal morphology after three loading injections (central foveal thickness (CFT), intraretinal cysts and serous neuroepithelium detachment). Changes in CFT after 3 months were our primary outcome measure. Association of SNPs to response was assessed by binomial logistic regression. Replication was attempted by associating visual acuity changes to genotypes in an independent Japanese cohort.ResultsAssociation with treatment response was detected for seven SNPs, including in FLT4 (rs55667289: OR=0.746, 95% CI 0.63 to 0.88, p=0.0005) and KDR (rs7691507: OR=1.056, 95% CI 1.02 to 1.10, p=0.005; and rs2305945: OR=0.963, 95% CI 0.93 to 1.00, p=0.0472). Only association with rs55667289 in FLT4 survived multiple testing correction. This SNP was unavailable for testing in the replication cohort. Of six SNPs tested for replication, one was significant although not after multiple testing correction.ConclusionIdentifying genetic variants that define treatment response can help to develop individualised therapeutic approaches for wet ARMD patients and may point towards new targets in non-responders.

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