Intravitreal Ziv-Aflibercept : Safety Analysis in Eyes Receiving More Than Ten Intravitreal Injections

Singh, Sumit Randhir; Chattannavar, Goura; Ayachit, Apoorva; Pimentel, Miguel Cruz; Alfaro, Alex; Tiwari, Sarvesh; Heranjal, Abhishek; Subramanyam, Anand; Braimah, Imoro Zeba; Dhami, Abhinav; Sachdev, Parineeta; Mansour, Ahmad M.; Chhablani, Jay

doi:10.1080/08820538.2019.1686528

Cited by 9 publications

(5 citation statements)

References 24 publications

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“…The largest case series published to date where intravitreal Ziv-aflibercept is used as treatment for diverse macular pathologies (5914 patients) reported the following adverse effects: 1 case of endophthalmitis, 3 cases of intraocular inflammation, 1 case of conjunctival thinning and necrosis, and 1 case of scleral nodule, 1 case of central retinal artery obstruction. 2 , 11 , 13 , 16 Adverse events are not much different than any other antiangiogenic drug. Prior studies and our study are indicative that Ziv-aflibercept is a safe medication for short- and long-term ophthalmic use (the largest follow-up study was up to 48 months).…”

Section: Discussionmentioning

confidence: 99%

“… 10 There are many studies that have evaluated the safety of Ziv-aflibercept and resulted satisfactory for its use, 2 , 5 , 6 , 10 , 12 this is because the dose used 1.25 mg/0.05 mL of Ziv-aflibercept compared to the relatively large volume of an adult vitreous (4 mL) dilutes the small volume (0.05 mL) of medication, causing the intravitreal osmolarity to increase from 300 mOsm/kg to approximately 312 mOsm/kg, very much below the 500 mOsm/kg umbral required to cause damage to the retina (retinal detachment, loss of villi from the retinal pigment epithelium, hyperosmotic cytotoxicity). 5 , 8 , 13 , 17 Studies have also been performed using 2 mg/0.08mL and 2.5 mg/0.1mL, and no differences were found regarding safety and effectiveness compared to 1.25 mg/0.05 mL. 9 , 10 , 16 , 18–20 …”

Section: Discussionmentioning

confidence: 99%

“…5 , 8–10 Studies carried out with Ziv-aflibercept for ophthalmological use have demonstrated to be safe for human use. 2 , 5 , 6 , 10 , 12 , 13 …”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of the Use of Three-Dose Intravitreal Ziv-Aflibercept in the Management of Diabetic Macular Edema in a Real-Life Setting

Munayco-Guillén¹,

Vázquez-Membrillo²,

García-Roa³

et al. 2023

OPTH

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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) mm 3 and post-treatment 9.3 (0–13.6) mm 3 [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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Effectiveness of the Use of Three-Dose Intravitreal Ziv-Aflibercept in the Management of Diabetic Macular Edema in a Real-Life Setting

Munayco-Guillén¹,

Vázquez-Membrillo²,

García-Roa³

et al. 2023

OPTH

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“…The ocular adverse events observed in a large retrospective study of 5914 IVZ were consistent with the safety profile of aflibercept and other anti-VEGF agents [ 18 ]. Further safety profile was provided by a retrospective study of eyes who received at least 10 IVZ injections [ 20 ]. Paulose et al [ 15 ] observed anterior chamber flare in one eye following IVZ injection in 9 eyes with RVO.…”

Section: Discussionmentioning

confidence: 99%

“…There are few reports on the safety and efficacy of off-label intravitreal ziv-aflibercept (IVZ) in patients with ME secondary RVO [14][15][16][17][18][19][20]. However, no reports exist on the efficacy of IVZ in African patients with macular edema secondary to RVO.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of intravitreal ziv-aflibercept in patients with macular edema following retinal vein occlusion in Korle-Bu Teaching Hospital, Ghana: a retrospective case series

2021

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Aim To evaluate the efficacy of ziv-aflibercept in Ghanaian patients with macular edema (ME) secondary to retinal vein occlusion (RVO). Methodology In this retrospective study, the medical records of patients with ME secondary to RVO who had been treated with intravitreal ziv-aflibercept (IVZ) (1.25 mg/0.05 ml), as part of routine clinical practice, on pro re nata basis with a minimum follow-up of 6 months were retrieved and analyzed. The main outcome measures are mean change in best-corrected visual acuity (BCVA) and central subfield foveal thickness (CSFT) measured on optical coherence tomography from baseline to 12 months post-IVZ, and ocular and systemic safety. Results Forty-three eyes were included in this study. Their mean age was 62.8 ± 11.9 years, 67.4% had at least 12-month duration of follow-up, 50% had primary open-angle glaucoma and 38 (88.4%) eyes were treatment naive. There was significant improvement in mean BCVA in LogMAR at 1 month post-initiation of IVZ (0.8 ± 0.5 vs. 1.1 ± 0.6), and visual improvement was maintained up to 12 months (p < 0.001). Eyes with ME following BRVO had better mean BCVA at baseline and on subsequent visits compared to eyes with CRVO/HRVO (p = 0.01). There was significant reduction in mean CSFT up to 12 months post-IVZ injection compared to baseline (p < 0.001). Ocular complications observed were consistent with complications associated with RVO. Conclusion We have observed significant improvement in functional and anatomic outcomes 12 months post-initiation of IVZ. There is the need to confirm long-term efficacy and safety of IVZ in a large prospective study.

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Intravitreal Ziv-Aflibercept : Safety Analysis in Eyes Receiving More Than Ten Intravitreal Injections

Cited by 9 publications

References 24 publications

Effectiveness of the Use of Three-Dose Intravitreal Ziv-Aflibercept in the Management of Diabetic Macular Edema in a Real-Life Setting

Effectiveness of the Use of Three-Dose Intravitreal Ziv-Aflibercept in the Management of Diabetic Macular Edema in a Real-Life Setting

Efficacy of intravitreal ziv-aflibercept in patients with macular edema following retinal vein occlusion in Korle-Bu Teaching Hospital, Ghana: a retrospective case series

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