Suraj Bala, Gabriel C S Barbosa, Nitesh Mohan, Sunil K Srivastava, Peter K Kaiser, Ananth Sastry, Amy S Babiuch, Jonathan Sears, Katherine E Talcott, Alex Yuan, Aleksandra Rachitskaya, Justis P Ehlers, Andrew P Schachat, Phoebe Lin, Sumit Sharma, Danny A Mammo
{"title":"Initial Functional and Anatomical Outcomes of High-Dose Aflibercept 8 mg in Exudative Neovascular Age-Related Macular Degeneration.","authors":"Suraj Bala, Gabriel C S Barbosa, Nitesh Mohan, Sunil K Srivastava, Peter K Kaiser, Ananth Sastry, Amy S Babiuch, Jonathan Sears, Katherine E Talcott, Alex Yuan, Aleksandra Rachitskaya, Justis P Ehlers, Andrew P Schachat, Phoebe Lin, Sumit Sharma, Danny A Mammo","doi":"10.1016/j.oret.2025.02.002","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the short-term outcomes of patients with exudative neovascular age-related macular degeneration (nAMD) treated with high-dose aflibercept 8.0 mg (HDA), focusing on anatomical and functional changes, as well as the feasibility of extending treatment intervals in real-world clinical practice.</p><p><strong>Design: </strong>Retrospective, noncomparative cohort study.</p><p><strong>Subjects: </strong>219 eyes from 184 patients with nAMD who received at least three HDAs between August 2023 and October 2024.</p><p><strong>Methods: </strong>Patients included in this study were either treatment-naïve or had been previously treated with other anti-VEGF agents. Clinical outcomes, including best-corrected visual acuity (BCVA) and macular OCT parameters, were evaluated at baseline and after each HDA.</p><p><strong>Main outcomes: </strong>The primary outcome was the proportion of eyes able to sustain an 8 ± 1 week or longer treatment interval without anatomical deterioration. Secondary outcomes included anatomical and functional changes.</p><p><strong>Results: </strong>The average follow-up time was 22.9 ± 4.9 weeks. 209 eyes (95.4%) were previously treated, and 10 eyes (4.6%) were treatment-naïve. After the first three injections, 206 eyes (94.1%) received a fourth HDA and 70 eyes (31.9%) received a fifth HDA. 102 eyes (46.6%) of the total cohort with an interval shorter than 8 weeks after three initial injections had persistent macular fluid. 24 eyes (11.0%) were switched to another anti-VEGF agent. Overall, the mean BCVA was 61.9 ± 21.7 ETDRS letters at baseline and 61.7 ± 22.6 at the final visit, with no statistically significant difference observed (p = 0.934). Central subfield thickness and pigment epithelial detachment height remained stable. Significant reductions were observed in subretinal (54.3% to 41.1%, p = 0.006) and intraretinal fluid (53.9% to 39.3%, p = 0.002). Among previously treated eyes, the mean pre-switch treatment interval was 5.8 ± 2.5 weeks and increased to 7.4 ± 2.2 weeks after the three initial injections (p < 0.0001).</p><p><strong>Conclusions: </strong>HDA demonstrated stable BCVA and significant reductions in macular fluid during the follow-up period. A considerable proportion of patients were unable to extend treatment intervals to at least 8-weeks due to persistent macular fluid. These findings suggest that HDA maintains functional stability while improving anatomic outcomes, though real-world challenges in managing chronic nAMD may limit the ability to extend treatment intervals.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4000,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ophthalmology. Retina","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.oret.2025.02.002","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: To evaluate the short-term outcomes of patients with exudative neovascular age-related macular degeneration (nAMD) treated with high-dose aflibercept 8.0 mg (HDA), focusing on anatomical and functional changes, as well as the feasibility of extending treatment intervals in real-world clinical practice.
Subjects: 219 eyes from 184 patients with nAMD who received at least three HDAs between August 2023 and October 2024.
Methods: Patients included in this study were either treatment-naïve or had been previously treated with other anti-VEGF agents. Clinical outcomes, including best-corrected visual acuity (BCVA) and macular OCT parameters, were evaluated at baseline and after each HDA.
Main outcomes: The primary outcome was the proportion of eyes able to sustain an 8 ± 1 week or longer treatment interval without anatomical deterioration. Secondary outcomes included anatomical and functional changes.
Results: The average follow-up time was 22.9 ± 4.9 weeks. 209 eyes (95.4%) were previously treated, and 10 eyes (4.6%) were treatment-naïve. After the first three injections, 206 eyes (94.1%) received a fourth HDA and 70 eyes (31.9%) received a fifth HDA. 102 eyes (46.6%) of the total cohort with an interval shorter than 8 weeks after three initial injections had persistent macular fluid. 24 eyes (11.0%) were switched to another anti-VEGF agent. Overall, the mean BCVA was 61.9 ± 21.7 ETDRS letters at baseline and 61.7 ± 22.6 at the final visit, with no statistically significant difference observed (p = 0.934). Central subfield thickness and pigment epithelial detachment height remained stable. Significant reductions were observed in subretinal (54.3% to 41.1%, p = 0.006) and intraretinal fluid (53.9% to 39.3%, p = 0.002). Among previously treated eyes, the mean pre-switch treatment interval was 5.8 ± 2.5 weeks and increased to 7.4 ± 2.2 weeks after the three initial injections (p < 0.0001).
Conclusions: HDA demonstrated stable BCVA and significant reductions in macular fluid during the follow-up period. A considerable proportion of patients were unable to extend treatment intervals to at least 8-weeks due to persistent macular fluid. These findings suggest that HDA maintains functional stability while improving anatomic outcomes, though real-world challenges in managing chronic nAMD may limit the ability to extend treatment intervals.