Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial
Suthasinee Sinawat,1,2 Suthasinee Hemanak,1 Kwanchanok Chanthowong,1 Supat Sinawat,3 Yosanan Yospaiboon1,2 1Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 2KKU Eye Center, Khon Kaen University, Khon Kaen, Thailand; 3Department of Physiology, Faculty of M...
| المؤلفون الرئيسيون: | , , , |
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| التنسيق: | مقال |
| اللغة: | English |
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Dove Medical Press
2023-09-01
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| سلاسل: | Clinical Ophthalmology |
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| الوصول للمادة أونلاين: | https://www.dovepress.com/intravitreal-ziv-aflibercept-versus-bevacizumab-for-nave-central-retin-peer-reviewed-fulltext-article-OPTH |
| _version_ | 1827810684874784768 |
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| author | Sinawat S Hemanak S Chanthowong K Sinawat S Yospaiboon Y |
| author_facet | Sinawat S Hemanak S Chanthowong K Sinawat S Yospaiboon Y |
| author_sort | Sinawat S |
| collection | DOAJ |
| description | Suthasinee Sinawat,1,2 Suthasinee Hemanak,1 Kwanchanok Chanthowong,1 Supat Sinawat,3 Yosanan Yospaiboon1,2 1Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 2KKU Eye Center, Khon Kaen University, Khon Kaen, Thailand; 3Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, ThailandCorrespondence: Suthasinee Sinawat; Yosanan Yospaiboon, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, 123 Mitraparb Highway, Khon Kaen, 40002, Thailand, Tel +66-4336-3010, Fax +66-4334-8383, Email ssuthasinee@kku.ac.th; yyosanan@gmail.comPurpose: To compare the efficacy of intravitreal ziv-aflibercept (IVZ) and bevacizumab (IVB) injections for the treatment of macular edema secondary to central retinal vein occlusion.Methods: Participants were randomly assigned 1:1 to receive 3 monthly IVZ (1.25 mg/0.05 mL) or IVB (1.25 mg/0.05 mL) followed by the pro-re-nata protocol for persistent or recurrent macular edema. The primary outcomes were best-corrected visual acuity and central subfield thickness. An interim analysis was planned when half of the participants completed the follow-up.Results: Twenty-four participants were recruited. At 6 months, mean best-corrected visual acuity in the IVB and IVZ groups improved from 1.23 ± 0.64 to 0.76 ± 0.56 logMAR (p = 0.003) and from 1.13 ± 0.59 to 0.53 ± 0.26 logMAR (p = 0.003), respectively. The percentage of visual improvement and reduction in central subfield thickness in the IVZ group were insignificantly better than those in the IVB group (44.41 ± 26.72 vs 39.64 ± 24.22%; p = 0.65) and (51.94 ± 20.35 vs 45.78 ± 24.71%; p = 0.51), respectively. Although the mean number of injections was lower in the IVZ group (4.55 ± 1.29 vs 4.82 ± 1.33), the difference was not statistically significant (p = 0.68). No ocular or systemic adverse events were observed.Conclusion: The interim analysis demonstrated that the visual and anatomical results of IVZ were insignificantly better than those of IVB at 6 months of follow-up. The results also showed that IVZ was non-inferior to IVB for anatomical improvement but inconclusive for visual improvement.Clinical Trial Registration: (identifier: TCTR20191205008).Keywords: ziv-aflibercept, bevacizumab, central retinal vein occlusion, macular edema |
| first_indexed | 2024-03-11T22:55:05Z |
| format | Article |
| id | doaj.art-e3de5b1f627a46b8957f6a02dca807a7 |
| institution | Directory Open Access Journal |
| issn | 1177-5483 |
| language | English |
| last_indexed | 2024-03-11T22:55:05Z |
| publishDate | 2023-09-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Clinical Ophthalmology |
| spelling | doaj.art-e3de5b1f627a46b8957f6a02dca807a72023-09-21T19:08:59ZengDove Medical PressClinical Ophthalmology1177-54832023-09-01Volume 172719272886750Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority TrialSinawat SHemanak SChanthowong KSinawat SYospaiboon YSuthasinee Sinawat,1,2 Suthasinee Hemanak,1 Kwanchanok Chanthowong,1 Supat Sinawat,3 Yosanan Yospaiboon1,2 1Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 2KKU Eye Center, Khon Kaen University, Khon Kaen, Thailand; 3Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, ThailandCorrespondence: Suthasinee Sinawat; Yosanan Yospaiboon, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, 123 Mitraparb Highway, Khon Kaen, 40002, Thailand, Tel +66-4336-3010, Fax +66-4334-8383, Email ssuthasinee@kku.ac.th; yyosanan@gmail.comPurpose: To compare the efficacy of intravitreal ziv-aflibercept (IVZ) and bevacizumab (IVB) injections for the treatment of macular edema secondary to central retinal vein occlusion.Methods: Participants were randomly assigned 1:1 to receive 3 monthly IVZ (1.25 mg/0.05 mL) or IVB (1.25 mg/0.05 mL) followed by the pro-re-nata protocol for persistent or recurrent macular edema. The primary outcomes were best-corrected visual acuity and central subfield thickness. An interim analysis was planned when half of the participants completed the follow-up.Results: Twenty-four participants were recruited. At 6 months, mean best-corrected visual acuity in the IVB and IVZ groups improved from 1.23 ± 0.64 to 0.76 ± 0.56 logMAR (p = 0.003) and from 1.13 ± 0.59 to 0.53 ± 0.26 logMAR (p = 0.003), respectively. The percentage of visual improvement and reduction in central subfield thickness in the IVZ group were insignificantly better than those in the IVB group (44.41 ± 26.72 vs 39.64 ± 24.22%; p = 0.65) and (51.94 ± 20.35 vs 45.78 ± 24.71%; p = 0.51), respectively. Although the mean number of injections was lower in the IVZ group (4.55 ± 1.29 vs 4.82 ± 1.33), the difference was not statistically significant (p = 0.68). No ocular or systemic adverse events were observed.Conclusion: The interim analysis demonstrated that the visual and anatomical results of IVZ were insignificantly better than those of IVB at 6 months of follow-up. The results also showed that IVZ was non-inferior to IVB for anatomical improvement but inconclusive for visual improvement.Clinical Trial Registration: (identifier: TCTR20191205008).Keywords: ziv-aflibercept, bevacizumab, central retinal vein occlusion, macular edemahttps://www.dovepress.com/intravitreal-ziv-aflibercept-versus-bevacizumab-for-nave-central-retin-peer-reviewed-fulltext-article-OPTHziv-afliberceptbevacizumabcentral retinal vein occlusionmacular edema |
| spellingShingle | Sinawat S Hemanak S Chanthowong K Sinawat S Yospaiboon Y Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial Clinical Ophthalmology ziv-aflibercept bevacizumab central retinal vein occlusion macular edema |
| title | Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial |
| title_full | Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial |
| title_fullStr | Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial |
| title_full_unstemmed | Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial |
| title_short | Intravitreal Ziv-Aflibercept versus Bevacizumab for Naïve Central Retinal Vein Occlusion with Macular Edema: An Interim Analysis of a Randomized Non-Inferiority Trial |
| title_sort | intravitreal ziv aflibercept versus bevacizumab for na iuml ve central retinal vein occlusion with macular edema an interim analysis of a randomized non inferiority trial |
| topic | ziv-aflibercept bevacizumab central retinal vein occlusion macular edema |
| url | https://www.dovepress.com/intravitreal-ziv-aflibercept-versus-bevacizumab-for-nave-central-retin-peer-reviewed-fulltext-article-OPTH |
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