Safety of 5914 intravitreal ziv-aflibercept injections

Singh, Sumit Randhir; Stewart, Michael W.; Chattannavar, Goura; Ashraf, Mohammed; Souka, Ahmed; ElDardeery, Mazen; Wadhwa, Neeraj; Sarvaiya, Chintan; Mansour, Ahmad M.; Marashi, Ameen; Ramchandani, Suresh; Braimah, Imoro Zeba; Bonyadi, Mohammad Reza; Ramezani, Alireza; Soheilian, Masoud; Dias, João Rafael de Oliveira; Andrade, Gabriel Costa de; Maia, André; Rodrigues, Eduardo Büchele; Farah, Michel Eid; Banker, Alay; Chhablani, Jay

doi:10.1136/bjophthalmol-2018-312453

Cited by 31 publications

(33 citation statements)

References 24 publications

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“…Additionally, the improvement in BCVA and the reduction in CMT after injection were achieved in both groups, with statistical significance that reflects the efficacy of the new drug in myopic CNV patients with a high safety profile and low cost. This finding was quite similar to those from recent studies performed on ziv-aflibercept on a larger number of patients [ 32 , 33 ] that discussed the application of ziv-aflibercept in different retinal diseases and detected a reasonable safety profile for the drug comparable with those of other anti-VEGF agents. Moreover, Braimah et al [ 11 ] studied the efficacy of ziv-aflibercept on retinal diseases other than AMD, such as high myopia, macular telangiectasia, central serous chorioretinopathy, choroidal osteoma, choroiditis, Best’s disease and idiopathic macular degeneration, and reported a marked reduction in CMT and a moderate improvement in BCVA.…”

Section: Discussionsupporting

confidence: 91%

Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients

Nawar

Shafik

2020

BMC Ophthalmol

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Background Myopic choroidal neovascularization (CNV) is the most common sight-threatening complication associated with high myopia. The present study evaluated the efficacy and safety of the intravitreal injection of ziv-aflibercept in patients with myopic CNV. Methods This prospective interventional study was conducted on 20 eyes of 20 patients with active myopic CNV. Twelve patients were 40 years or older. This study was performed in the Ophthalmology Department of Tanta University Eye Hospital, Tanta University, Egypt. Optical coherence tomography (OCT) was performed for all patients at baseline and monthly after injection during the 6-month follow up period. The main outcome measures were changes in BCVA and CMT. The exploratory outcome measures were CNV size, IOP and the number of injections needed in each age group during the study period. Results Patients with myopic CNV younger than 40 years needed fewer injections (2.00 ± 0.76) than patients older than 40 years (2.50 ± 1.00), with no statistical significance detected between the two groups (p-value 0.246). CNV was smaller in the younger age group (p-value 0.209), best corrected visual acuity (BCVA) improved significantly in the younger and older age groups (p-values 0.001 and 0.028, respectively), and central macular thickness (CMT) decreased significantly after 6 months, from 242.88 ± 23.83 μm to 191.13 ± 13.83 μm in the younger age group and from 251.33 ± 26.60 μm to 197.08 ± 17.64 μm in the older age group (p = 0.001). No significant correlation was found between the final BCVA and either the spherical equivalent or central macular thickness after 6 months, with p-values of 0.135 and 0.145, respectively. No significant changes in IOP were detected in either group after the intravitreal injection. Conclusion Ziv-aflibercept is a highly effective and safe drug in cases of active myopic CNV; however, a larger number of patients and a longer follow-up period are needed to confirm our results. This study was retrospectively registered at clinicaltrials.gov (ID: NCT04290195) on 26-2-2020.

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Section: Discussionsupporting

confidence: 91%

Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients

Nawar

Shafik

2020

BMC Ophthalmol

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“…Serious systemic adverse events included 2 cases of CVAs, 2 deaths and 1 myocardial infarct were also noted, but could not be definitively linked to the use of ziv-aflibercept. It was concluded that the safety profile of ziv-aflibercept was similar to that of commercially available anti-VEGF IVT agents [44].…”

Section: Ziv-afliberceptmentioning

confidence: 92%

RETRACTED ARTICLE: Pharmacological agents in development for diabetic macular edema

et al. 2020

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Background: Diabetic macular edema (DME) is the leading cause of visual loss in patients with diabetic retinopathy. There has been a paradigm shift in the treatment of DME since the advent of anti-vascular endothelial growth factor (anti-VEGF) therapy. The safety and efficacy of anti-VEGF therapy has been well established. Although efficacious, currently approved anti-VEGF agents are associated with certain limitations, which include, among others: frequent need for injections, high treatment cost and variable response to treatment. These challenges have led to an active search for more novel agents that may be able to overcome these limitations. Areas covered: The index review focuses on novel treatment agents that target various pathways in patients with DME. These agents are used either as monotherapy or in combination with other agents in the management of DME. Drugs discussed include novel anti-VEGF inhibitors, TIE-2 receptor modulators, integrin peptide inhibitors, rho kinase inhibitors, and future therapies such as neuroprotection and gene therapy. Conclusions: The future of investigational pharmacological therapy appears promising for patients with DME. Results from early clinical trials indicate that newer agents highlighted in the study may be safe and efficacious treatment options for patients with DME. However, data from large multicenter clinical trials need to be analyzed before these agents can be incorporated into clinical practice.

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“…Any ocular or systemic side effects were noted and were considered injection or procedure related if occurred within 1 month of intravitreal injections. [20]…”

Section: Methodsmentioning

confidence: 99%

Bevacizumab versus ziv-aflibercept in branch retinal vein occlusion

Braimah

Singh

Uplanchiwar

et al. 2019

Indian J Ophthalmol

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Purpose: To compare the effectiveness of treatment with intravitreal bevacizumab (IVB) and ziv-aflibercept (IVZ) in patients with macular edema (ME) post-branch retinal vein occlusion (BRVO). Methods: Patients with treatment naïve ME post-BRVO were included retrospectively if they received either IVB (0.05 ml/1.25 mg) or IVZ (0.05 ml/1.25 mg) monotherapy with a follow up of 12 months. Results: Thirty-two and 17 eyes received IVB and IVZ, respectively. The mean improvement in best corrected visual acuity (BCVA) was 0.36 ± 0.3 logarithm of minimum angle of resolution (logMAR) in the IVB group and 0.27 ± 0.3 in the IVZ group ( P = 0.35). The mean change in central macular thickness was 178.9 ± 180.9 and 173.5 ± 344.4 μm in IVB and IVZ groups, respectively ( P = 0.94). The mean number of injections was higher in the IVB group (4.0 ± 1.8) compared with 1.82 ± 0.8 in the IVZ group ( P < 0.0001). The IVZ group had significantly fewer number of visits ( P < 0.0001) and longer maximum treatment-free intervals ( P = 0.0081). Conclusion: IVZ appears to be cost-effective with the similar visual outcome and less number of visits in comparison to IVB.

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Safety of 5914 intravitreal ziv-aflibercept injections

Cited by 31 publications

References 24 publications

Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients

Pilot study of ziv-aflibercept in myopic choroidal neovascularisation patients

RETRACTED ARTICLE: Pharmacological agents in development for diabetic macular edema

Bevacizumab versus ziv-aflibercept in branch retinal vein occlusion

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