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Comparison of intravitreal ranibizumab and aflibercept for the treatment of diabetic macular edema: a real-world study

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Abstract

Purpose

To compare the visual and anatomic outcomes of intravitreal ranibizumab versus aflibercept in patients with diabetic macular edema (DME) in a real-world study.

Methods

This is a single-center retrospective comparative study of treatment-naïve patients who received intravitreal ranibizumab or aflibercept administration for DME for at least 12 months on an as needed regimen following three-monthly loading doses. The primary outcomes of the study were the mean change in best-corrected visual acuity (BCVA), central macular thickness (CMT), and central macular volume (CMV). Factors to potentially affect these parameters were also analyzed.

Results

A total of 100 eyes (66 patients) were included in the study. Fifty two eyes received ranibizumab and 48 eyes in aflibercept injections. At the end of follow-up, the improvement in mean BCVA was similar in both groups (p = 0.38). While the decrease in mean CMT at the 4th-month visit was significantly higher in the aflibercept-treated group than in the ranibizumab-treated group (p = 0.02), there was no difference between the two groups at the end of the 1-year follow-up (p = 0.25). There was no significant difference between the two groups in terms of change in mean CMV during the follow-up (p = 0.26, p = 0.27 at 4 and 12 months, respectively). The mean number of injections were also similar between groups (4.5 ± 1 vs. 4.6 ± 1.1 respectively, p = 0.63).

Conclusion

In a real-world setting, ranibizumab and aflibercept were both found to be effective in the first-line treatment of DME. Patients with DME who received fewer injections in the real-world could achieve visual and anatomical results comparable to randomized controlled trials participants.

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Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Authors

Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Puren Isik, Selcuk Sizmaz, Ebru Esen, Anıl Uysal and Nihal Demircan. The first draft of the manuscript was written by Puren Isik and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Puren Isik.

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Competing interests

The authors have no relevant financial or non-financial interests to disclose.

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Cukurova University Board of Clinical Research and Ethics (22 January 2021, 107/30). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Isik, P., Sizmaz, S., Esen, E. et al. Comparison of intravitreal ranibizumab and aflibercept for the treatment of diabetic macular edema: a real-world study. Int Ophthalmol 43, 4171–4180 (2023). https://doi.org/10.1007/s10792-023-02820-0

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