Abstract and Introduction
Purpose To report outcome of eyes with recalcitrant and naive eyes with diabetic macular edema (DME) treated with intravitreal dexamethasone implants (Ozurdex) injection.
Methods Retrospective multicenter data analysis of eyes with DME treated with Ozurdex implant and with minimum follow-up of at least one year after the first implant. Data collected included demographic details, history of presenting illness, past treatment history, clinical examination details including visual acuity at presentation, and follow-up with imaging and treatment details. Paired sample t-test was used to measure mean differences between pre- and post-implant values obtained at baseline and last follow-up.
Results A total of 79 eyes (62 subjects) were included. Sixty-four eyes had been previously treated; 15 eyes were naive. Among the previously treated eyes, mean interval between first Ozurdex injection and any previous treatment was 7.69±8.2 months. In naive eyes, the visual acuity improved from baseline 0.58±0.25 to 0.44±0.33 logMAR at last follow-up (P=0.05). In eyes that had been previously treated, the improvement was from 0.65±0.34 at baseline to 0.48±0.35 logMAR (P=0.01). Mean treatment-free interval was 6.5±4.5 months. Nine eyes were steroid responder with controlled intraocular pressure (IOP), none showed any spike in IOP during the follow-up period.
Conclusions Ozurdex implant could be a good alternative for recalcitrant as well as naive eyes with DME. The visual gain after initial implant injection was fairly maintained, with additional treatment usually after 6 months in naive eyes. Ozurdex appeared safe even in steroid responders with good control of IOP with antiglaucoma medications.
Various treatment modalities have been tried in management of diabetic macular edema (DME) including laser photocoagulation, intravitreal triamcinolone acetonide (IVTA), and antivascular endothelial growth factor (VEGF) therapy. Laser photocoagulation, the first-line treatment suggested by early-treatment diabetic retinopathy study (ETDRS), has recently taken a step back. The Diabetic Retinopathy Clinical Research (DRCR) Network protocol (I) reported good results with IVTA injections, however, the side effects of cataract progression and increase in intraocular pressure (IOP) limit its use in clinical practice. Limitations of fluocinolone acetonide vitreous inserts include increase in IOP and its cost, which limits its use in clinical practice. Anti-VEGF injections with or without laser photocoagulation has become first-line treatment of DME. However, the limitations of anti-VEGF injections include frequent injections, induction of resistance, and tachyphylaxis due to the long-term nature of the treatment. Cases of DME that do not respond well to regular anti-VEGF injections may be driven by proinflammatory cytokines other than VEGF.
Most recently (June 2014), the FDA approved Ozurdex for the treatment of DME in the general population. However, the European Union's Committee for Medicinal Products for Human Use (CHMP) has recommended extending the marketing authorization for Ozurdex to treat adult patients with vision loss due to DME who are pseudophakic or who are considered insufficiently responsive to or unsuitable for noncorticosteroid therapy.
Recent clinical trials PLACID and MEAD reported efficacy of Ozurdex with or without laser photocoagulation in management of DME.[5,6] However, these trials had fixed retreatment interval, and thus the efficacy of this implant at shorter interval could not be assessed. It would be interesting to evaluate the results from clinical trials in routine clinical practice. Moreover, the comparison between the efficacy of this implant in resistant and naive cases for longer follow-up has not been reported before.
This multicenter retrospective study reports treatment outcome in recalcitrant and naive eyes with DME.
Eye. 2016;30(3):426-430. © 2016 Nature Publishing Group