Abstract
Purpose:
The Swedish Macula Register (SMR) is a national quality register for treatment of age-related maculadegeneration (AMD) established in 2003 and since 2007 are 99% of the treatments intravitreal injections (IVI). SMR analyze results (improvement of vision) related to age, gender, type of lesion, number and type of treatments per clinic/county. Adverse events (AE) are reported to the register . SMR has a coverage of 82%.
Methods:
AE are registered and a comparison with Medical Products Agency Sweden (MPA) of severe AE has been conducted 2007- 2012. A survey of operative routines of IVI has been sent to all eye clinics in Sweden treating wet AMD november 2013.
Results:
SMR december 2013 includes 15305 patients, 17505 eyes, 230205 visits and105325 treatments. Mean age for start of IVI is 79 years of age and 64% of patients are female. Improvement of visual acuity after 12 months of treatment was ≥5 letters for 43% and ≥15 letters for 16% The number of injections in the first year of treatment has increased 2007-2012. During 2007-2011 98% of all IVI were Ranibizumab. Since sep 2011 there is an increase in use of Bevicizumab and 2013 when Aflibercept was introduced it was quickly adapted in Sweden. December 2013 39,6% of all IVI for AMD are Ranibizumab, 25,2% Bevicizumab and 34,5% Aflibercept. The registration of postoperative endophthalmitis 2007-2012 were 23 cases. The incidence has increased 2008 0,25‰ to 2012 0,35‰. Suspected systemic AE has increased 2010-2012 with 6 reported cases 2010 to 48 2012.This is an incidence 2010 of 1,0‰ and 2012 5,73‰ per patient. MPA has received 12 cases of endophthalmitis 2007-2012 and 115 cases of suspected systemic AE. The survey of IVI was answered by 35 of 39 clinics. IVI are performed in operation theatre (92%) and sterile room in office (8%). Antibiotics are used on the day of injection in 32 clinics and only 3 clinics give no antibiotics in IVI with anti-VEGF.
Conclusions:
The number of patients, treatments and follow-up visits has increased every year. The incidence of endophthalmitis increased 2007 to 2012. Suspected systemic AE has increased 2010-2012 20 cases has been judged by MPA to have connection with the IVI 40% cardiovascular and 45% cerebrovascular AE. IVI are performed in operation theatre in most eye clinics in Sweden. 90% of clinics give antibiotics in conjunction with IVI. SMR will 2014 start a register for endophthalmitis after IVI.
Keywords: 412 age-related macular degeneration •
462 clinical (human) or epidemiologic studies: outcomes/complications