https://orcid.org/0000-0002-8035-4874
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Abstract
Purpose
It has been reported that intravitreal Ziv-aflibercept is a safe and effective drug for the treatment of diabetes macular edema (DME). The objective of this study was to evaluate in a real-life setting, the efficacy of intravitreal Ziv-aflibercept in the treatment of DME after the administration of three consecutive monthly doses.
Methods
A single arm, prospective cohort study. We included patients with DME who received three doses of intravitreal Ziv-aflibercept. Data such as best corrected visual acuity (BCVA) and tomographic biomarkers before treatment and a month after the third dose were collected. DME was staged using the Panozzo classification.
Results
Thirty-eight patients participated for a total of 53 eyes. The mean age was 59 ± 8.1 years. We observed significant changes after the third dose in the parameters studied (BCVA in LogMAR pre-treatment (0.6 ± 0.33) and post-treatment (0.4 ± 0.29) [p<0.001], macular thickness pre-treatment (501 ± 167 µm) and post-treatment (324 ± 114 µm) [p<0.001], macular volume pre-treatment 10.8 (7.5–17.8) mm3 and post-treatment 9.3 (0–13.6) mm3 [p<0.005]). And 73.6% of the patients presented an advanced severe stage during their pre-treatment evaluation and after post-treatment, 64.2% of the patients no longer presented edema. No systemic or ocular adverse events occurred.
Conclusion
The use of three consecutive monthly doses of intravitreal Ziv-aflibercept in a real-life setting is effective and safe in the management of diabetic macular edema.
Summary Statement
Ziv-aflibercept is an antiangiogenic drug with a chemical structure similar to aflibercept. In prior studies, it has been shown to be effective and safe for the treatment of diabetic macular edema and other macular pathologies. It constitutes an excellent alternative treatment due to its easy transportation, storage, distribution, lower cost and application techniques similar to other antiangiogenics.
Ethics Approval and Informed Consent
This research was approved by the Research Ethics Committee of the Mexican Institute of Ophthalmology with authorization number: CEI/IMO-019/2021 and the Research Committee of the Mexican Institute of Ophthalmology with authorization number: CI/IMO-013-4/2021. All patients included in this study were asked to sign a consent form.
Acknowledgments
To the directors of the Mexican Ophthalmology Institute and the Department of Retina and Vitreous Surgery personnel for the facilities granted to carry out this study.
Author Contributions
All authors meet the following authorship criteria:
Made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas.
Have drafted or written, or substantially revised or critically reviewed the article.
Have agreed on the journal to which the article will be submitted.
Reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage.
Agree to take responsibility and be accountable for the contents of the article.
Disclosure
The authors report no conflicts of interest in this work.