XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration
Abstract Introduction XTEND (NCT03939767) is a multicenter, observational, prospective study of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in routine clinical practice. The study aims to examine treatment outcomes of proactive intravitreal aflibercept (IVT-AFL)...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Adis, Springer Healthcare
2024-01-01
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| Series: | Ophthalmology and Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1007/s40123-023-00867-x |
| _version_ | 1797275616250167296 |
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| author | Jean-François Korobelnik Varun Chaudhary Paul Mitchell Se Woong Kang Ramin Tadayoni Helmut Allmeier JinKyung Lee Xin Zhang Tobias Machewitz Clare Bailey |
| author_facet | Jean-François Korobelnik Varun Chaudhary Paul Mitchell Se Woong Kang Ramin Tadayoni Helmut Allmeier JinKyung Lee Xin Zhang Tobias Machewitz Clare Bailey |
| author_sort | Jean-François Korobelnik |
| collection | DOAJ |
| description | Abstract Introduction XTEND (NCT03939767) is a multicenter, observational, prospective study of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in routine clinical practice. The study aims to examine treatment outcomes of proactive intravitreal aflibercept (IVT-AFL) treatment regimens (fixed dosing or treat-and-extend) according to local marketing labels. Methods Study eyes received IVT-AFL injections as per the local label. The mean changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to month (M) 12 and M24 were measured and stratified by baseline factors. Treatment exposure and safety data were evaluated. Statistical analysis was descriptive. Results Overall, 1466 patients from 17 countries were treated. For the overall population, the mean ± standard deviation (SD) age was 78.7 ± 8.5 (range 50–100) years, and 891 patients (60.8%) were female. The mean ± SD baseline BCVA was 54.3 ± 20.3 letters and CST was 374 ± 126 µm. At M12 and M24, mean (95% confidence interval [CI]) BCVA change was + 4.3 (3.4, 5.3) and + 2.3 (1.3, 3.3) letters, respectively. Mean (95% CI) CST was − 106 (− 114, − 99) μm and − 109 (− 117, − 102) μm at M12 and M24, respectively. At M24, 41.5% of patients had a BCVA ≥ 70 letters. Patients received a mean ± SD of 7.7 ± 2.7 injections by M12 and 10.8 ± 5.0 injections by M24 (3.1 injections between M12 and M24). Adverse events were consistent with the known safety profile of IVT-AFL. Conclusion The 24-month results indicate that, in routine clinical practice, a proactive IVT-AFL regimen achieves functional improvements in patients with treatment-naïve nAMD. The proportion of patients achieving ≥ 70 letters at M24 increased, and patients with baseline BCVA ≥ 70 letters maintained vision regardless of the followed IVT-AFL label. Trial registration ClinicalTrials.gov identifier: NCT03939767. Video abstract A video abstract is available for this article. Supplementary file2 (MP4 364624 KB) |
| first_indexed | 2024-03-07T15:16:03Z |
| format | Article |
| id | doaj.art-5dccedef5d574aafb0c91b5f6d2bb66b |
| institution | Directory Open Access Journal |
| issn | 2193-8245 2193-6528 |
| language | English |
| last_indexed | 2024-03-07T15:16:03Z |
| publishDate | 2024-01-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Ophthalmology and Therapy |
| spelling | doaj.art-5dccedef5d574aafb0c91b5f6d2bb66b2024-03-05T17:54:04ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282024-01-0113372573810.1007/s40123-023-00867-xXTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular DegenerationJean-François Korobelnik0Varun Chaudhary1Paul Mitchell2Se Woong Kang3Ramin Tadayoni4Helmut Allmeier5JinKyung Lee6Xin Zhang7Tobias Machewitz8Clare Bailey9Service d’Ophtalmologie, CHU BordeauxHamilton Regional Eye Institute, St. Joseph’s HealthcareWestmead Institute for Medical Research–University of SydneySamsung Medical Center, Sungkyunkwan UniversityOphthalmology Department, Université Paris Cité, AP-HP, Lariboisière and Saint Louis HospitalsBayer Consumer Care AGBayer AGBayer Consumer Care AGBayer AGBristol Eye HospitalAbstract Introduction XTEND (NCT03939767) is a multicenter, observational, prospective study of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in routine clinical practice. The study aims to examine treatment outcomes of proactive intravitreal aflibercept (IVT-AFL) treatment regimens (fixed dosing or treat-and-extend) according to local marketing labels. Methods Study eyes received IVT-AFL injections as per the local label. The mean changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to month (M) 12 and M24 were measured and stratified by baseline factors. Treatment exposure and safety data were evaluated. Statistical analysis was descriptive. Results Overall, 1466 patients from 17 countries were treated. For the overall population, the mean ± standard deviation (SD) age was 78.7 ± 8.5 (range 50–100) years, and 891 patients (60.8%) were female. The mean ± SD baseline BCVA was 54.3 ± 20.3 letters and CST was 374 ± 126 µm. At M12 and M24, mean (95% confidence interval [CI]) BCVA change was + 4.3 (3.4, 5.3) and + 2.3 (1.3, 3.3) letters, respectively. Mean (95% CI) CST was − 106 (− 114, − 99) μm and − 109 (− 117, − 102) μm at M12 and M24, respectively. At M24, 41.5% of patients had a BCVA ≥ 70 letters. Patients received a mean ± SD of 7.7 ± 2.7 injections by M12 and 10.8 ± 5.0 injections by M24 (3.1 injections between M12 and M24). Adverse events were consistent with the known safety profile of IVT-AFL. Conclusion The 24-month results indicate that, in routine clinical practice, a proactive IVT-AFL regimen achieves functional improvements in patients with treatment-naïve nAMD. The proportion of patients achieving ≥ 70 letters at M24 increased, and patients with baseline BCVA ≥ 70 letters maintained vision regardless of the followed IVT-AFL label. Trial registration ClinicalTrials.gov identifier: NCT03939767. Video abstract A video abstract is available for this article. Supplementary file2 (MP4 364624 KB)https://doi.org/10.1007/s40123-023-00867-xAfliberceptAge-related macular degenerationClinical trialIntravitrealMaculaNeovascularization |
| spellingShingle | Jean-François Korobelnik Varun Chaudhary Paul Mitchell Se Woong Kang Ramin Tadayoni Helmut Allmeier JinKyung Lee Xin Zhang Tobias Machewitz Clare Bailey XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration Ophthalmology and Therapy Aflibercept Age-related macular degeneration Clinical trial Intravitreal Macula Neovascularization |
| title | XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration |
| title_full | XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration |
| title_fullStr | XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration |
| title_full_unstemmed | XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration |
| title_short | XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration |
| title_sort | xtend two year results from a global observational study investigating proactive dosing of intravitreal aflibercept in neovascular age related macular degeneration |
| topic | Aflibercept Age-related macular degeneration Clinical trial Intravitreal Macula Neovascularization |
| url | https://doi.org/10.1007/s40123-023-00867-x |
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