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Clinical science
Safety of 5914 intravitreal ziv-aflibercept injections
  1. Sumit Randhir Singh1,
  2. Michael W Stewart2,
  3. Goura Chattannavar1,
  4. Mohammed Ashraf3,
  5. Ahmed Souka3,
  6. Mazen ElDardeery3,
  7. Neeraj Wadhwa4,
  8. Chintan Sarvaiya5,
  9. Ahmad M Mansour6,7,
  10. Ameen Marashi8,
  11. Suresh Ramchandani9,
  12. Imoro Zeba Braimah10,11,
  13. Mohammad Hossein Jabbarpoor Bonyadi12,
  14. Alireza Ramezani12,13,14,
  15. Masoud Soheilian12,13,
  16. João Rafael de Oliveira Dias15,
  17. Gabriel Costa de Andrade15,
  18. André Maia15,
  19. Eduardo Büchele Rodrigues15,
  20. Michel Eid Farah15,
  21. Alay Banker5,
  22. Jay Chhablani1
  23. on behalf of the Ziv-aflibercept Study Group
    1. 1 Smt. Kanuri Santhamma Centre for Vitreo-Retinal Diseases, L V Prasad Eye Institute, Hyderabad, India
    2. 2 Department of Ophthalmology, Mayo Clinic, Jacksonville, Florida, USA
    3. 3 Department of Ophthalmology, Alexandria Faculty of Medicine, Alexandria University, Alexandria, Egypt
    4. 4 Foresight Eye Clinic, New Delhi, India
    5. 5 Banker’s Retina Clinic and Laser Centre, Ahmedabad, India
    6. 6 Department of Ophthalmology, American University of Beirut, Beirut, Lebanon
    7. 7 Department of Ophthalmology, Rafik Hariri University Hospital, Beirut, Lebanon
    8. 8 Marashi Eye Clinic, Aleppo, Syria
    9. 9 Shivam Eye Foundation, Navi Mumbai, Maharashtra, India
    10. 10 Department of Surgery, School of Medicine and Dentistry, University of Ghana, Accra, Ghana
    11. 11 Eye Centre, Korle- Bu Teaching Hospital, Accra, Ghana
    12. 12 Ophthalmic Research Center, Labbafinejad Medical Center, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
    13. 13 Negah Eye Hospital, Tehran, Iran
    14. 14 Torfe Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
    15. 15 Department of Ophthalmology, Federal University of São Paulo - Paulista Medical School (UNIFESP/EPM), São Paulo, Brazil
    1. Correspondence to Dr Jay Chhablani, Smt. Kanuri Santhamma Centre for Vitreo-Retinal Diseases, L V Prasad Eye Institute, Hyderabad 500034, India; jay.chhablani{at}gmail.com

    Abstract

    Purpose To analyse the pooled safety data of intravitreal ziv-aflibercept (IVZ) therapy for various retinal conditions.

    Methods This was a retrospective, observational study which included patients from 14 participating centres who received IVZ. The medical records of patients who received IVZ from March 2015 through October 2017 were evaluated. Patient demographics and ocular details were compiled. Ocular and systemic adverse events that occurred within 1 month of IVZ injections were recorded and defined as either procedure-related or drug-related.

    Results A total of 1704 eyes of 1562 patients received 5914 IVZ injections (mean±SD: 3.73±3.94) during a period of 2.5 years. The age of patients was 60.6±12.8 years (mean±SD) and included diverse chorioretinal pathologies. Both ocular (one case of endophthalmitis, three cases of intraocular inflammation, and one case each of conjunctival thinning/necrosis and scleral nodule) and systemic adverse events (two cases of myocardial infarction, one case of stroke and two deaths) were infrequent.

    Conclusion This constitutes the largest pooled safety report on IVZ use and includes patients from 14 centres distributed across the globe. It shows that IVZ has an acceptable ocular and systemic safety profile with incidences of adverse events similar to those of other vascular endothelial growth factor inhibitory drugs. The analysis supports the continued use of IVZ in various retinal disorders.

    • retinal venous occlusion (RVO)
    • ziv-aflibercept.
    • intravitreal ziv-aflibercept (IVZ)
    • diabetic macular edema (DME)
    • neovascular age related macular degeneration (n-AMD)

    https://doi.org/10.1136/bjophthalmol-2018-312453

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      Footnotes

      • Collaborators Mudit Tyagi, Rajeev Reddy Pappuru, Taraprasad Das, Padmaja Kumari Rani, Raja Narayanan, Vivek Pravin Dave, Subhadra Jalali, Divya Balakrishnan, Hitesh Agrawal, Komal Agrawal, Mohammed Abdul Rasheed, Ahmadreza Baghi, Mehdi Yaseri, Chintan Dedhia, Chetan Videkar, Muchai Gachago, Bhushan Uplanchiwar, Kushal Agrawal, Remya Paulose, Mahima Jhingan, Vishal Govindhari, Rushil Kumar Saxena, Avadesh Oli, Ravi Sharma, Avantika Dogra, Rajan Gupta, Nallamasa Rohit.

      • Contributors SRS, MA, AMM, MEF and JC were involved in the design of the study. GC, MA, AS, MED, NW, CS, AmM, SR, IZB, MHJB, AR, JRdOD, GCdA, AnM, EBR and AB were involved in the collection of data. SRS, GC, MA and JC were responsible for interpretation and analysis of the data. SRS, MA, AMM, AmM, MWS, MED and AB were involved in manuscript writing. MWS, MA, AR, MS, JRdOD, MEF, AB and JC reviewed the article. All the authors conducted the study and equally contributed in the preparation, review and approval of the manuscript.

      • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

      • Competing interests None declared.

      • Patient consent Obtained.

      • Ethics approval L V Prasad Eye Institute Institutional Review Board. Prior institute review board (IRB) approval of the study was obtained from each centre and the study adhered to the tenets of the Declaration of Helsinki.

      • Provenance and peer review Not commissioned; externally peer reviewed.

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