Eyeworld

EW RETINA 70 December 2016 by Stefanie Petrou Binder, MD, EyeWorld Contributing Writer treatment somewhat less effective. Our outcomes are based on the first and only dexamethasone implant injection. So far we have results of up to 80 days post-injection. We will be following patients for 120 days and have the completed results available. At 80 days, however, we already have a much longer duration of action and equal efficacy using this implant as seen with anti-VEGF therapy." The outcomes of the current clinical investigation support data from a report that studied dexa- methasone intravitreal implants in DME, as well as other DME ther- apy options. 1 The authors stated that Phase 2 and 3 clinical trials of Ozurdex intravitreal dexamethasone implants for DME demonstrated a mean increase in visual acuity and corresponding mean reduction in central macular thickness in pseudophakic eyes. According to the report, dexamethasone steroid implants are reserved for use in patients who are unresponsive to anti-VEGF agents due largely to the risk of cataract, which would com- pound the visual loss in DME eyes, as well as the additional risks of glaucoma and intraocular infection. The authors recommend Ozurdex as a first line treatment option in eyes with center-involving DME including eyes with pseudophakia, impending cataract surgery, or in the context of a recent arterial thromboembolic event. The report treatments for DME. The first line patients (n=10) were 100% pseu- dophakic, and 30% were pre-treated with subthreshold laser treatments. In the second line group (n=18), 61% were pseudophakic, 39% were phakic, and 80% had laser pre-treat- ment. The patients were all over 50 years of age. The mean BCVA summarized in both subgroups was 0.6±0.4 at baseline, 0.5±0.4 at week 1, 0.6±0.4 at week 6, and 0.4±0.3 at week 12 logMAR. Mean CST was 428±128 µm at baseline, and 388±62 µm, 305±83 µm, and 380±143 µm at follow-up time points week 1, week 6, and week 12, respectively. Four of the 28 eyes (14%) showed an increase in IOP that was greater than or equal to 10 mm Hg, of which three eyes required anti-glaucoma medication. "Vitrectomized eyes and the eyes that had been pre-treated with anti-VEGF sometimes experienced shorter effects from the dexameth- asone implant than eyes without vitrectomy or anti-VEGF pre-treat- ments," said Hakan Kaymak, MD, partner, Breyer, Kaymak & Klabe Augenchirurgie, and senior partner, Internationale Innovative Ophthal- mochirurgie. "In vitrectomized eyes, this may be due to the fact that removal of part of the vitreous mass can reduce the length of time intra- vitreal pharmacologic agents remain within the eye, increasing the wash- out of the drug, and shortening the length of drug interaction, making period was 120 days in the subgroup of native versus non-native patients. The primary end points were best corrected visual acuity (BCVA), central subfield thickness (CST), and intraocular pressure (IOP). "This implant has long-term effects lasting anywhere from 3 to 6 months," said Andreas Fricke, PhD, Breyer, Kaymak & Klabe Augenchir- urgie, Düsseldorf, Germany, and International Vision Correction Research Network. "In elderly pa- tients or patients who have difficulty visiting the doctor on a monthly basis, either because they live far away or are abroad frequently, the practicality of needing to repeat injections every 3 to 6 months as opposed to every month, as we need to do with anti-VEGF injections, is very attractive for patients and treat- ing ophthalmologists alike. It is also much more comfortable for patients, and they are less likely to object to having these injections or to what otherwise might be an inconvenient and uncomfortable treatment ex- perience." Dr. Fricke was part of the investigative group and presented the study results. The study included 28 eyes of 25 patients. Ten eyes were treated with dexamethasone as first line therapy, meaning that they had no pre-treatment with anti-VEGF agents, and 18 eyes received the dexamethasone implant as a second line therapy, having already un- dergone unsuccessful anti-VEGF New German study substantiates long- acting effects of implant I ntravitreal therapy has become the first line treatment option for the management of dia- betic macular edema (DME). Dexamethasone implants have matched the visual and macular- slimming results attained through the use of anti-vascular endothelial growth factor (VEGF) injections, with the added advantage of longer steroid effects, meaning fewer injec- tions and happier patients. New data show that intravitreal dexamethasone implants (Ozurdex, Allergan, Dublin, Ireland) were safe and effective in non-glaucomatous eyes with DME, achieving greatly improved visual acuity outcomes of between eight and nine letters of im- provement as well as a reduction in central subfield thickness of close to 100 µm, according to study results presented at the 2016 Congress of German Ophthalmic Surgeons. The retrospective observation- al study evaluated the efficacy of Ozurdex intravitreal dexamethasone implants using 22-gauge needles for the first line treatment of DME versus its use as second line treat- ment. The study included phakic and pseudophakic patients with per- sistent DME and excluded individ- uals with glaucoma or a history of ocular hypertension. The follow-up Dexamethasone implant as first line therapy for DME IOP >80 days post-dexamethasone Presentation spotlight Central subfield thickness >80 days post-dexamethasone Source: Andreas Fricke, PhD

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