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      Three-Year Outcomes of Patients with Neovascular Age-Related Macular Degeneration Treated with Aflibercept under the National Health Insurance Program in Taiwan

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          Abstract

          Purpose

          To observe and analyze the long-term outcomes of patients with neovascular age-related macular degeneration (nAMD) treated with aflibercept monotherapy under the National Health Insurance (NHI) program in Taiwan.

          Methods

          This retrospective observational study was conducted at Taipei Veterans General Hospital. Patients with naive nAMD who were treated with aflibercept and followed for more than 3 years were reviewed. The better eye was enrolled if both eyes were affected. Visual acuity (VA) and central macular thickness (CMT) were recorded for 3 years. The lost-to-follow-up rate, number of injections, and predictive factors for visual outcomes were analyzed.

          Results

          Ninety-nine eyes in 99 patients were followed up for 3 years. The mean age at onset of nAMD was 82.8 ± 9.26 years, and 65% of the patients were male. Compared with initial visual acuity, 5 (5.1%) of our patients improved their vision for 3 or more lines after 3 years of follow-up, 11 (11.1%) of our patients improved for 1 to 3 lines, 62 (62.6%) patients remained their vision with 1 line or less changes, 15 (15.2%) patients lost their vision for 1 to 3 lines, and 6 (6%) patients lost their vision for 3 or more lines. The CMT was 359 ± 180  µm before treatment and 259 ± 98 after 3 years ( p < 0.001). The mean number of injections was 4.63 ± 1.91 in the first year, 2.13 ± 2.2 in the second year, and 1.42 ± 1.79 in the third year. Multivariate analysis showed that final VA was significantly associated with VA at year 1, the presence of retinal pigment epithelial detachment at year 1, and receiving more than four injections in the first year. Final CMT was only significantly associated with CMT at year 1.

          Conclusion

          After 3 years of treatment under the NHI program in Taiwan, 21.2% of the patients with nAMD still had a visual decline despite good anatomical outcomes. More aggressive treatment or other strategies should be used for patients who may have a poor prognosis.

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          Ranibizumab and bevacizumab for neovascular age-related macular degeneration.

          Daniel Martin, Maureen Maguire, Gui-shuang Ying … (2011)
          Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data. In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart. Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern. At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).
          Article 0 comments Cited 727 times – based on 0 reviews     Review now
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            Five-Year Outcomes with Anti-Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration: The Comparison of Age-Related Macular Degeneration Treatments Trials.

            Maureen Maguire, Daniel Martin, Gui-Shuang Ying … (2016)
            To describe outcomes 5 years after initiating treatment with bevacizumab or ranibizumab for neovascular age-related macular degeneration (AMD).
            Article 0 comments Cited 235 times – based on 0 reviews     Review now
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              An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration.

              Anne Fung, Geeta A Lalwani, Philip J. Rosenfeld … (2007)
              To evaluate an optical coherence tomography (OCT)-guided, variable-dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD). Open-label, prospective, single-center, nonrandomized, investigator-sponsored clinical study. In this two-year study, neovascular AMD patients with subfoveal choroidal neovascularization (CNV) (n = 40) and a central retinal thickness of at least 300 microm as measured by OCT were enrolled to receive three consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes was observed between visits: a loss of five letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 microm, new-onset classic CNV, new macular hemorrhage, or persistent macular fluid detected by OCT at least one month after the previous injection of ranibizumab. At month 12, the mean visual acuity improved by 9.3 letters (P < .001) and the mean OCT central retinal thickness decreased by 178 microm (P < .001). Visual acuity improved 15 or more letters in 35% of patients. These visual acuity and OCT outcomes were achieved with an average of 5.6 injections over 12 months. After a fluid-free macula was achieved, the mean injection-free interval was 4.5 months before another reinjection was necessary. This OCT-guided, variable-dosing regimen with ranibizumab resulted in visual acuity outcomes similar to the Phase III clinical studies, but required fewer intravitreal injections. OCT appears useful for determining when retreatment with ranibizumab is necessary.
              Article 0 comments Cited 223 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                De-Kuang Hwang:
                ORCID: https://orcid.org/0000-0001-6346-8485
                Journal
                Journal ID (nlm-ta): J Ophthalmol
                Journal ID (iso-abbrev): J Ophthalmol
                Journal ID (publisher-id): JOPH
                Title: Journal of Ophthalmology
                Publisher: Hindawi
                ISSN (Print): 2090-004X
                ISSN (Electronic): 2090-0058
                Publication date Collection: 2020
                Publication date (Electronic): 21 February 2020
                Volume: 2020
                Electronic Location Identifier: 4538135
                Affiliations
                1Department of Ophthalmology, Taipei Veterans General Hospital, Taipei, Taiwan
                2Department of Ophthalmology, Shin Kong Wu Ho Su Memorial Hospital, Taipei, Taiwan
                3Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan
                4Institute of Pharmacology, National Yang-Ming University, Taipei, Taiwan
                5Department of Ophthalmology, School of Medicine, National Yang-Ming University, Taipei, Taiwan
                Author notes

                Guest Editor: Ali Dirani

                Author information
                https://orcid.org/0000-0002-7008-6829
                https://orcid.org/0000-0002-6998-4226
                https://orcid.org/0000-0001-6346-8485
                https://orcid.org/0000-0001-9798-1578
                Article
                DOI: 10.1155/2020/4538135
                PMC ID: 7057014
                SO-VID: 951ab625-d8fe-40b6-b32a-0e69b72d05ce
                Copyright © Copyright © 2020 Kang-Jung Lo et al.
                License:

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 23 October 2019
                Date revision received : 22 January 2020
                Date accepted : 31 January 2020
                Categories
                Subject: Research Article

                ScienceOpen disciplines: Ophthalmology & Optometry
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry

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