Switching to ziv-aflibercept in resistant diabetic macular edema non responsive to ranibizumab injection

Amin E Nawar, Tamer Wasfy, Heba M Shafik, Amin E Nawar, Tamer Wasfy, Heba M Shafik

Abstract

Background: Diabetic macular edema (DME) is a leading cause of visual loss in diabetic patients and is managed using multiple anti-vascular endothelial growth factor (VEGF) agents such as bevacizumab, ranibizumab and aflibercept. The present study evaluates effectiveness of intravitreal injection of ziv-aflibercept in resistant diabetic macular edema.

Methods: This is a prospective interventional study that was carried out on 59 eyes of 40 diabetic patients with diabetic macular edema resistant to three prior consecutive ranibizumab injections. On all patients, thorough ophthalmic evaluation including optical coherence tomography was performed. In patients with persistent intraretinal or subretinal fluid, ziv- aflibercept 1.25 mg (0.05 ml) was administered by intravitreal injection monthly during the 6 month study period from June to December 2019.

Results: The central macular thickness (CMT) decreased significantly from 395.08 ± 129.9 um at baseline to 282.39 ± 95.278, 245.36 ± 79.861 and 201.17 ± 54.042 after 1, 3 and 6 months of treatment respectively (p < 0.001). Best corrected visual acuity (BCVA) in log MAR units was significantly improved from 0.95 ± 0.21 to 0.51 ± 0.23 after 6 months (p = 0.001). After treatment, negative correlations were detected between age, number of injections, duration of DM and level of glycated hemoglobin (HbA1c) and variation of both CMT and BCVA. The only significant predictor for low final CMT after 6 months of injection was the CMT after 3 months of injection (p = 0.001).

Conclusion: Ziv-aflibercept is a highly effective and safe drug in cases of DME resistant to previous ranibizumab injections especially in low-income countries.

Trial registration: This study was retrospectively registered at clinicaltrials.gov (ID: NCT04290195) on 28-2-2020.

Keywords: Diabetic macular edema; Intravitreal injection; Optical coherence tomography; Ziv-aflibercept.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Variation in mean central macular thickness (um) before and after ziv-aflibercept injection
Fig. 2
Fig. 2
Variation in mean BCVA by logMAR before and after ziv-aflibercept injections
Fig. 3
Fig. 3
A case of bilateral diabetic macular edema with CMT 426 um in the right eye (A), and 334 um in the left eye (B). The BCVA is 1(log MAR) in the right eye and 0.82 (log MAR) in the left eye
Fig. 4
Fig. 4
OCT of the case shown in Fig. 3 after 3 loading doses of ranibizumab in each eye. The CMT did not decrease after injection, the CMT is 593 um in the right eye (A) and 363 um in the left eye (B); the BCVA did not improve after injection, the BCVA is 1 (log MAR) in the right eye and 0.82 (log MAR) in the left eye
Fig. 5
Fig. 5
OCT of the case shown in Fig. 3 after one month of the first injection of ziv-aflibercept. The CMT decreased to 292 um in the right eye (A) and 220 um in the left eye (B)
Fig. 6
Fig. 6
OCT of the case shown in Fig. 3 after 3 injections of ziv-aflibercept (after 3 months). The CMT decreased to 262 um in the right eye (A) and 197 um in the left eye (B)
Fig. 7
Fig. 7
OCT of the case shown in Fig. 3 after 6 ziv-aflibercept injections (after 6 months) showing decreased CMT to 253 um in the right eye (A) and 158 um in the left eye (B); the BCVA improved to 0.3 (log MAR) in the right eye and 0.4 (log MAR) in the left eye

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Source: PubMed

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