TY - JOUR
T1 - Safety of 6000 intravitreal dexamethasone implants
AU - International Ozurdex Study Group
AU - Rajesh, Bindu
AU - Zarranz-Ventura, Javier
AU - Fung, Adrian T.
AU - Busch, Catharina
AU - Sahoo, Niroj Kumar
AU - Rodriguez-Valdes, Patricio J.
AU - Sarao, Valentina
AU - Mishra, Sanjay Kumar
AU - Saatci, A. Osman
AU - Udaondo Mirete, Patricia
AU - Querques, Giuseppe
AU - Farah, Michel Eid
AU - Lanzetta, Paolo
AU - Arevalo, J. Fernando
AU - Kodjikian, Laurent
AU - Chhablani, Jay
N1 - Funding Information:
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).
Publisher Copyright:
© Author(s) (or their employer(s)) 2020.
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
KW - drugs
KW - treatment medical
KW - vision
KW - vitreous
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U2 - 10.1136/bjophthalmol-2019-313991
DO - 10.1136/bjophthalmol-2019-313991
M3 - Article
C2 - 31040132
AN - SCOPUS:85065248393
SN - 0007-1161
VL - 104
SP - 39
EP - 46
JO - British Journal of Ophthalmology
JF - British Journal of Ophthalmology
IS - 1
ER -