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Safety of 6000 intravitreal dexamethasone implants
  1. Bindu Rajesh1,
  2. Javier Zarranz-Ventura2,
  3. Adrian T Fung3,4,
  4. Catharina Busch5,
  5. Niroj Kumar Sahoo6,
  6. Patricio J Rodriguez-Valdes7,
  7. Valentina Sarao8,
  8. Sanjay Kumar Mishra9,
  9. A Osman Saatci10,
  10. Patricia Udaondo Mirete11,
  11. Giuseppe Querques12,
  12. Michel Eid Farah13,
  13. Paolo Lanzetta14,
  14. J Fernando Arevalo15,
  15. Laurent Kodjikian16,17,
  16. Jay Chhablani6
  17. for International Ozurdex Study Group
    1. 1 Khoo Teck Puat Hospital, Singapore, Singapore
    2. 2 Hospital Clínic de Barcelona Insi, Instituto Clinic de Barcelona, Instituto Clinic de Oftalmología (ICOF), Barcelona, Spain
    3. 3 Department of Ophthalmology, Westmead Hospital, Sydney, Australian Capital Territory, Australia
    4. 4 Save Sight Institute, Sydney Eye Hospital, University of Sydney, Sydney, New South Wales, Australia
    5. 5 Department of Ophthalmology, Universitatsklinikum Leipzig, Leipzig, Germany
    6. 6 Vitreo-retina, L V Prasad Eye Institute, Hyderabad, Andhra Pradesh, India
    7. 7 Ophthalmology, Instituto de Oftalmología y Ciencias Visuales, Escuela de Medicina, Tecnológico de Monterrey, San Pedro Garza García, Mexico
    8. 8 Department of Medicine-Ophthalmology, University of Udine, Udine, Italy
    9. 9 11 Department of Ophthalmology, Command Hospital, Lucknow, India
    10. 10 Dokuz Eylul University, Izmir, Turkey
    11. 11 13 Ophthalmology Department, Hospital Universitario La Fe, Valencia, Spain
    12. 12 Ophthalmology, Ospedale San Raffaele, Milano, Italy
    13. 13 Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil
    14. 14 University of Udine, Udine, Italy
    15. 15 Retina and Vitreous, Clinica Oftalmologica Centro Caracas, Caracas, Venezuela
    16. 16 Ophthalmology, Croix-Rousse University Hospital, Hospices Civils de Lyon, Lyon, France
    17. 17 CNRS UMR 5510 Mateis, University of Lyon, Lyon, France
    1. Correspondence to Dr Jay Chhablani, Vitreo-retina, L V Prasad Eye Institute, Hyderabad, AP 500034, India; jay.chhablani{at}gmail.com

    Abstract

    Purpose To evaluate the real-life safety profile of intravitreal dexamethasone implant injection for various retinal conditions.

    Methods Retrospective multicenter analysis of intravitreal dexamethasone implant injections (700 µg) due to various retinal conditions including central retinal venous occlusion (1861 injections), diabetic macular oedema (3104 injections), post-surgical cystoid macular oedema (305 injections) and uveitis (381 injections). The eyes were evaluated mainly for the occurrence of adverse events such as glaucoma, cataract, retinal detachment and endophthalmitis along during the follow-up period.

    Results A total of 6015 injections in 2736 eyes of 1441 patients (mean age of 65.7±12.9 years) were in total analysed over an average period of 18 months (range 6 months to 102 months). A total of 576 eyes (32.5% of the phakic eyes) developed cataract requiring surgical intervention. However, visually insignificant cataract progression was observed in another 259 phakic eyes (14.6%) which did not require surgical removal. A total of 727 eyes (26.5%) experienced an intraocular pressure (IOP) rise of >25 mm Hg, with 155 eyes (5.67%) having a prior history of glaucoma and 572 eyes (20.9%) having new onset IOP rise. Overall, more than 90% of eyes with IOP rise were managed medically, and 0.5% eyes required filtering surgery. Endophthalmitis (0.07%), retinal detachment (0.03%) and vitreous haemorrhage (0.03%) were rare. There was no significant change in visual acuity (p=0.87) and central macular thickness (p=0.12) at the last follow-up.

    Conclusion This is the largest real-life study assessing the safety of intravitreal dexamethasone implant injections in various retinal conditions. Cataract progression and intraocular pressure rise are the most common side effects, but are often rather easily manageable.

    • drugs
    • treatment medical
    • vitreous
    • vision
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    • Collaborators International Ozurdex Study Group: A. Gupta (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). A. Singh (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Abhilash Goud (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034). Ahmad mansour (Department of Ophthalmology, American University of Beirut, Beirut, Lebanon., Department of Ophthalmology, Rafic Hariri University Hospital, Beirut, Lebanon). Alay Banker (Banker's Retina Clinic and Laser Centre, Ahmedabad, India). Alok C Sen (Department of Retina and Uvea, Sadguru Netra Chikitsalya, Chitrakoot). Ameen Marashi (ameenmarashi@hotmail.com, Marashi Eye Clinic, Aleppo, Syria.) Andre Maia (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil.) Aniruddha Maiti (Sushrut eye foundation, Kolkata, India) Anna Sala-Puigdollers (Vitreo-Retinal Unit, Institut Clínic d’Oftalmologia (ICOF), Hospital Clínic, Barcelona) Ashish Sharma (Lotus eye hospital, Coimbatore, India) Carlo Cagini(Section of Ophthalmology, Department of Biomedical and Surgical Sciences, University of Perugia, Perugia, Italy.) Carolina Bernal-Morales (Vitreo-Retinal Unit, Institut Clínic d’Oftalmologia (ICOF), Hospital Clínic, Barcelona) Chintan Sarvaiya (Banker's Retina Clinic and Laser Centre, Ahmedabad, India.) Daniele Veritti (Department of Medicine-Ophthalmology, University of Udine, Udine, Italy, istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Dinah Zur (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Dua Masarwa (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Eduardo Novais (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Ermete Giancipoli (Department of Surgical, Microsurgical and Medical Sciences, Eye Clinic, University of Sassari, Sassari, Italy, Department of Biomedical Sciences, University of Sassari, Sassari, Italy.) Francesco Bandello (Department of Ophthalmology, University Vita Salute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy) Hasenin Al-khersan <haseninrh@gmail.com> (The University of Chicago, Pritzker School of Medicine, Chicago, IL) J S Wong (International Specialist Eye Centre, Kuala Lumpur, Malaysia) K. Raji (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Lihteh Wu (Apdo 144-1225 Plaza Mayor, San José, 1225, Costa Rica). Mali Okada (Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia). Manish Nagpal (Retina Foundation and Eye Research Center, Ahmedabad, India). Marcelo Casella (mbcasella@gmail.com, Department of Ophthalmology, Universidade Estadual de Londrina, Londrina, Brazil). Marco Lupidi (Section of Ophthalmology, Department of Biomedical and Surgical Sciences, University of Perugia, Perugia, Italy.) Marcos Avila (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Maria Berrocal (University of Puerto Rico School of Medicine, San Juan, Puerto Rico). Matias Iglicki (Private Retina Service, University of Buenos Aires, Buenos Aires, Argentina.) Mauricio Maia (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Michele Cavalleri (Department of Ophthalmology, University Vita Salute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy) Mohammed Abdul Rasheed (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034) Monica Asencio-Duran (Vitreo-Retinal Department, Hospital La Paz, Madrid) Nicolò Rassu (Department of Medicine-Ophthalmology, University of Udine, Udine, Italy; istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Oriana D’Anna-Mardero (Vitreo-Retinal Department, Hospital La Paz, Madrid) Pierre-Henry Gabrielle (Ophthalmology Department, Dijon University Hospital, Dijon, France. Center for Taste and Feeding Behaviour, INRA, UMR1324, Dijon, France). Prateek Shenoy (Department of Retina and Uvea, Sadguru Netra Chikitsalya, Chitrakoot) Roberto Gallego-Pinazo (Oftalvist Clinic, Valencia, Spain) Rosa Dolz Marco (Oftalvist Clinic, Valencia, Spain) S. Kumar (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India) S. Patyal (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Samantha Fraser-Bell (Department of Ophthalmology, Sydney University, Sydney, Australia). Shai Cohen (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Sumit Randhir Singh (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034) V. Sharma (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India) Valentina Sarao (sarao.valentina@gmail.com, istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Voraporn Chaikitmongkol (Retina Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand). Zafer Cebeci (Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey). Ziya Ayhan (Dokuz Eylul University, İzmir,Turkey).(Section of Ophthalmology, Department of Biomedical and Surgical Sciences, University of Perugia, Perugia, Italy.) Carolina Bernal-Morales (Vitreo-Retinal Unit, Institut Clínic d’Oftalmologia (ICOF), Hospital Clínic, Barcelona) Chintan Sarvaiya (Banker's Retina Clinic and Laser Centre, Ahmedabad, India.) Daniele Veritti (Department of Medicine-Ophthalmology, University of Udine, Udine, Italy, istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Dinah Zur (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Dua Masarwa (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Eduardo Novais (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Ermete Giancipoli (Department of Surgical, Microsurgical and Medical Sciences, Eye Clinic, University of Sassari, Sassari, Italy, Department of Biomedical Sciences, University of Sassari, Sassari, Italy.) Francesco Bandello (Department of Ophthalmology, University Vita Salute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy) Hasenin Al-khersan <haseninrh@gmail.com> (The University of Chicago, Pritzker School of Medicine, Chicago, IL) J S Wong (International Specialist Eye Centre, Kuala Lumpur, Malaysia) K. Raji (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Lihteh Wu (Apdo 144-1225 Plaza Mayor, San José, 1225, Costa Rica). Mali Okada (Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia). Manish Nagpal (Retina Foundation and Eye Research Center, Ahmedabad, India). Marcelo Casella (mbcasella@gmail.com, Department of Ophthalmology, Universidade Estadual de Londrina, Londrina, Brazil). Marco Lupidi (Section of Ophthalmology, Department of Biomedical and Surgical Sciences, University of Perugia, Perugia, Italy.) Marcos Avila (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Maria Berrocal (University of Puerto Rico School of Medicine, San Juan, Puerto Rico). Matias Iglicki (Private Retina Service, University of Buenos Aires, Buenos Aires, Argentina.) Mauricio Maia (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Michele Cavalleri (Department of Ophthalmology, University Vita Salute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy) Mohammed Abdul Rasheed (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034) Monica Asencio-Duran (Vitreo-Retinal Department, Hospital La Paz, Madrid) Nicolò Rassu (Department of Medicine-Ophthalmology, University of Udine, Udine, Italy; istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Oriana D’Anna-Mardero (Vitreo-Retinal Department, Hospital La Paz, Madrid) Pierre-Henry Gabrielle (Ophthalmology Department, Dijon University Hospital, Dijon, France. Center for Taste and Feeding Behaviour, INRA, UMR1324, Dijon, France). Prateek Shenoy (Department of Retina and Uvea, Sadguru Netra Chikitsalya, Chitrakoot) Roberto Gallego-Pinazo (Oftalvist Clinic, Valencia, Spain) Rosa Dolz Marco (Oftalvist Clinic, Valencia, Spain) S. Kumar (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India) S. Patyal (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Samantha Fraser-Bell (Department of Ophthalmology, Sydney University, Sydney, Australia). Shai Cohen (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Sumit Randhir Singh (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034) V. Sharma (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India) Valentina Sarao (sarao.valentina@gmail.com, istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Voraporn Chaikitmongkol (Retina Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand). Zafer Cebeci (Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey). Ziya Ayhan (Dokuz Eylul University, İzmir,Turkey).(Section of Ophthalmology, Department of Biomedical and Surgical Sciences, University of Perugia, Perugia, Italy.) Carolina Bernal-Morales (Vitreo-Retinal Unit, Institut Clínic d’Oftalmologia (ICOF), Hospital Clínic, Barcelona) Chintan Sarvaiya (Banker's Retina Clinic and Laser Centre, Ahmedabad, India.) Daniele Veritti (Department of Medicine-Ophthalmology, University of Udine, Udine, Italy, istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Dinah Zur (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Dua Masarwa (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Eduardo Novais (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Ermete Giancipoli (Department of Surgical, Microsurgical and Medical Sciences, Eye Clinic, University of Sassari, Sassari, Italy, Department of Biomedical Sciences, University of Sassari, Sassari, Italy.) Francesco Bandello (Department of Ophthalmology, University Vita Salute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy) Hasenin Al-khersan <haseninrh@gmail.com> (The University of Chicago, Pritzker School of Medicine, Chicago, IL) J S Wong (International Specialist Eye Centre, Kuala Lumpur, Malaysia) K. Raji (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Lihteh Wu (Apdo 144-1225 Plaza Mayor, San José, 1225, Costa Rica). Mali Okada (Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia). Manish Nagpal (Retina Foundation and Eye Research Center, Ahmedabad, India). Marcelo Casella (mbcasella@gmail.com, Department of Ophthalmology, Universidade Estadual de Londrina, Londrina, Brazil). Marco Lupidi (Section of Ophthalmology, Department of Biomedical and Surgical Sciences, University of Perugia, Perugia, Italy.) Marcos Avila (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Maria Berrocal (University of Puerto Rico School of Medicine, San Juan, Puerto Rico). Matias Iglicki (Private Retina Service, University of Buenos Aires, Buenos Aires, Argentina.) Mauricio Maia (Department of Ophthalmology and Visual Sciences, Universidade Federal de São Paulo, São Paulo, SP, Brazil). Michele Cavalleri (Department of Ophthalmology, University Vita Salute, IRCCS Ospedale San Raffaele, Via Olgettina, 60, 20132 Milan, Italy) Mohammed Abdul Rasheed (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034) Monica Asencio-Duran (Vitreo-Retinal Department, Hospital La Paz, Madrid) Nicolò Rassu (Department of Medicine-Ophthalmology, University of Udine, Udine, Italy; istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Oriana D’Anna-Mardero (Vitreo-Retinal Department, Hospital La Paz, Madrid) Pierre-Henry Gabrielle (Ophthalmology Department, Dijon University Hospital, Dijon, France. Center for Taste and Feeding Behaviour, INRA, UMR1324, Dijon, France). Prateek Shenoy (Department of Retina and Uvea, Sadguru Netra Chikitsalya, Chitrakoot) Roberto Gallego-Pinazo (Oftalvist Clinic, Valencia, Spain) Rosa Dolz Marco (Oftalvist Clinic, Valencia, Spain) S. Kumar (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India) S. Patyal (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India). Samantha Fraser-Bell (Department of Ophthalmology, Sydney University, Sydney, Australia). Shai Cohen (Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel). Sumit Randhir Singh (L.V.Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, HYDERABAD - 500 034) V. Sharma (Department of Ophthalmology Command hospital, Lucknow cantt 226002, India) Valentina Sarao (sarao.valentina@gmail.com, istituto Europeo di Microchirurgia Oculare-IEMO, Udine, Italy) Voraporn Chaikitmongkol (Retina Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand). Zafer Cebeci (Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey). Ziya Ayhan (Dokuz Eylul University, İzmir,Turkey).

    • Contributors All persons designated as authors qualify for authorship, and all those who qualify are listed. Each author has participated sufficiently in the work to take public responsibility for appropriate portions of the content. Design: JC. Conduct of the study: JZV, ATF, CB, NKS, PJRV, VS, SKM, AOS, PUM, GQ, MEF, PL, JFA, LK, JC. Collection: JZV, AF, CB, PJRV, VS, SKM, AOS, PUM, GQ, MEF, PL, JFA, LK, JC. Management: BR, JC. Analysis: BR, NKS, JC. Interpretation of the data: BR, NKS, JC. Preparation: BR, JZV, ATF, CB, NKS, PJRV, VS, SKM, AOS, PUM, GQ, MEF, PL, JFA, LK, JC. Review: BR, JZV, ATF, CB, NKS, PJRV, VS, SKM, AOS, PUM, GQ, MEF, PL, JFA, LK, JC. Approval of the manuscript: BR, JZV, ATF, CB, NKS, PJRV, VS, SKM, AOS, PUM, GQ, MEF, PL, JFA, LK, JC.

    • 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 BR: None JZ-V: Allergan (Consultant); Bayer (Consultant); ATF: Allergan (Consultant); Bayer (Consultant); CB: Allergan (Consultant); Bayer (Travel support); Novartis (Consultant) NKS: None PJR-V: Allergan, Alcon, Novartis, Bayer, Industrial Organica, SA de CV, Laboratorios Sophia VS: None SKM: None AOS: Allergan (Consultant); Bayer (Consultant); Novartis (Consultant) PUM: Bayer (Consultant); Centervue (Consultant); Novartis (Consultant) GQ: Allergan, Alcon, Novartis, Bayer, Industrial Organica, SA de CV, Laboratorios Sophia. MEF: None PL: Alcon (Consultant); Alimera (Consultant); Allergan (Consultant); Bausch&Lomb (Consultant); Bayer (Consultant); Boehringer (Consultant); CenterVue (Consultant); Genentech (Consultant); Lupin (Consultant); Lutronic (Consultant); Novartis Pharma AG (Consultant); Roche (Consultant); Teva (Consultant); Topcon (Consultant) JFA: TURING PHARMACEUTICALS LLC(Consultant); DORC International B.V. (Consultant); Allergan Inc. (Consultant); Bayer (Consultant); Mallinckrodt (Consultant); TOPCON (Grant Support) LK: Principal Investigator for trials sponsored by Novartis, Allergan, Bayer, Théa, Alcon; has sat on advisory boards for Alcon, Alimera, Allergan, Bayer, Roche, Novartis; lecture fees from Alcon, Alimera, Allergan, Bayer, Horus, Novartis, Théa. JC: Allergan (Consultant); Bayer (Consultant); Novartis (Consultant); OD-OS (Consultant).

    • Patient consent for publication Obtained.

    • Ethics approval Local Institutional ethics committee at all study sites.

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

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