Purpose Dexamethasone intravitreal implant (DEX implant 0.7 mg; OZURDEX®, Allergan, Inc.) is a FDA-EMA approved therapy for the treatment of macular edema (ME) secondary to Branch and Central retinal vein occlusion (BRVO and CRVO) and intermediate and posterior non-infectious uveitis. Aim of the study is to report the adverse events related to this treatment in the clinical practice. Methods We reviewed the charts of all consecutive patients affected by ME secondary to different pathologies, who had undergone DEX implant 0.7 mg.Patients were instructed to use antibiotics postoperatively and followed up for at least 4 months after injections. Adverse events following DEX implant were recorded. Results Forty-three eyes of 42 patients were included for analysis. ME was related to BRVO (15 eyes), CRVO (14 eyes) and diabetes (14 eyes). Overall, 45 injections (mean 1,1 injections/patient) were performed. The mean follow-up was 6,1 months. Most common adverse events were related to the injection, and included mild and transient foreign body sensation (77,8%), conjunctival hyperemia (71,1%), conjunctival edema (53,3%), conjunctival haemorrhage (53,3%), eye pain (28.9%). Increased intraocular pressure (<10mmHg change from baseline) occurred in 4 patients (8,9%) and was successfully managed with topical IOP-lowering medication. No vitreous haemorrhage or retina tear/detachment were registered. Infective endophthalmitis occurred in one patient (2.2%), who underwent vitrectomy and recovered good visual acuity.In two eyes (4,4%) cataract progressed and required surgery. In one of these eyes triamcinolone acetonide was injected before entering in this study. No systemic adverse events were detected over the follow-up. Conclusions Our data confirmed that the Dexamethasone intravitreal implant is safe and well-tolerated, being serious ocular adverse events rather uncommon. Remarkably, no systemic adverse events developed after the implant. Careful examination over the follow-up is strongly advised.
Adverse Events After Dexamethasone Intravitreal Implant
Battaglia Parodi M;Francesco Bandello
2012-01-01
Abstract
Purpose Dexamethasone intravitreal implant (DEX implant 0.7 mg; OZURDEX®, Allergan, Inc.) is a FDA-EMA approved therapy for the treatment of macular edema (ME) secondary to Branch and Central retinal vein occlusion (BRVO and CRVO) and intermediate and posterior non-infectious uveitis. Aim of the study is to report the adverse events related to this treatment in the clinical practice. Methods We reviewed the charts of all consecutive patients affected by ME secondary to different pathologies, who had undergone DEX implant 0.7 mg.Patients were instructed to use antibiotics postoperatively and followed up for at least 4 months after injections. Adverse events following DEX implant were recorded. Results Forty-three eyes of 42 patients were included for analysis. ME was related to BRVO (15 eyes), CRVO (14 eyes) and diabetes (14 eyes). Overall, 45 injections (mean 1,1 injections/patient) were performed. The mean follow-up was 6,1 months. Most common adverse events were related to the injection, and included mild and transient foreign body sensation (77,8%), conjunctival hyperemia (71,1%), conjunctival edema (53,3%), conjunctival haemorrhage (53,3%), eye pain (28.9%). Increased intraocular pressure (<10mmHg change from baseline) occurred in 4 patients (8,9%) and was successfully managed with topical IOP-lowering medication. No vitreous haemorrhage or retina tear/detachment were registered. Infective endophthalmitis occurred in one patient (2.2%), who underwent vitrectomy and recovered good visual acuity.In two eyes (4,4%) cataract progressed and required surgery. In one of these eyes triamcinolone acetonide was injected before entering in this study. No systemic adverse events were detected over the follow-up. Conclusions Our data confirmed that the Dexamethasone intravitreal implant is safe and well-tolerated, being serious ocular adverse events rather uncommon. Remarkably, no systemic adverse events developed after the implant. Careful examination over the follow-up is strongly advised.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
