Safety of 6000 intravitreal dexamethasone implants

Abstract

PurposeTo evaluate the real-life safety profile of intravitreal dexamethasone implant injection for various retinal conditions.MethodsRetrospective 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.ResultsA 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.ConclusionThis 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.

Local delivery of corticosteroids in clinical ophthalmology: A review

“…Mean IOP returned to baseline by month 6 after each injection, and there did not appear to be a cumulative effect on IOP elevation with repeated injections. Similar findings were found in a 12‐month trial by the OZURDEX PLACID Study Group and a recent large retrospective analysis of 2736 eyes of 1441 patients treated with a total of 6015 DII in which 26.5% of eyes had an IOP rise >25 mm Hg but only 0.91% required glaucoma filtration surgery …”

“…In the MEAD study for DMO, DII 0.7 mg was associated with cataract‐related adverse events in 67.9% of patients over the course of the 3‐year study, with 59.2% requiring cataract surgery during the study . A recent large retrospective analysis of over 6000 DII injections found a statistically significant increase in cataract progression in eyes receiving injections ( P = .004) although with a small co‐relation co‐efficient ( r = .057) …”

Can the dexamethasone intravitreal implant Ozurdex be safely administered in an out-of-operating room setting?

“…Regarding the safety profile, the incidence of endophthalmitis did not significantly differ from those reported in the literature [37][38][39][40][41] . Based on the currently available scientific evidence, intravitreal injections performed at the operating room did not have lower rates of endophthalmitis than those performed in the office [21][22][23][37][38][39][40][41] .…”

“…The incidence of endophthalmitis after intravitreal injections of anti-VEGF or corticosteroids is low [37][38][39][40][41] . In a Retrospective, nationwide multicenter case series conducted in France, which evaluated 316,576 intravitreal injections, the overall incidence of endophthalmitis was 0.021% (2.1 in 10,000 injections) (95% CI, 0.016%À0.026%) 37 .…”

Differential response to intravitreal dexamethasone implant in naïve and previously treated diabetic macular edema eyes

“…[51,52] However, the probability of taking IOP-lowering medication increased considerably from 12 months to 24 months, an important consideration when using the IDI in routine clinical care. [53] Our study has some limitations, such as the retrospective design of the study. In addition, a detailed comparison of the data obtained with that from previous clinical trials and other retrospective studies is complicated by the fact that they involve cohorts with different characteristics at baseline (Table 4).…”