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Ilaria Zucchiatti, Rosangela Lattanzio, Maria Lucia Cascavilla, Querques Lea, Del Turco Claudia, Querques Giuseppe, Francesco Bandello; Dexamethasone Intravitreal Implant In Patients With Refractory Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2012;53(14):404.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the effects of a single injection of dexamethasone intravitreal implant (DEX implant 0,7 mg, OZURDEX®, Allergan Inc., USA) over 6 months in eyes with refractory diabetic macular edema (DME).
In this retrospective interventional study, 9 eyes of 9 patients with vision loss owing to DME received DEX implant 0,7 mg. At baseline, all patients performed a complete ophthalmic evaluation included best-corrected visual acuity (BCVA), tonometry, fluorescein angiography and Spectral Domain Optical Coherence Tomography (SD-OCT) with Central Retinal Thickness (CRT) measurement. BCVA, fundus biomicroscopy, tonometry, SD-OCT were performed at the 3rd post-injection day and at the 1st, 3rd, 4th (5 out of 9 eyes) and 6th month. Main outcome measures included changes in BCVA and CRT.
The mean duration of DME was 49 months (range 24 to 85). All patients underwent previous treatments for DME (intravitreal injection of anti-VEGF, steroids or laser photocoagulation) before entering in the study. On SD-OCT, IS-OS interface was interrupted in 6 out 9 cases. At baseline mean BCVA was 0,74±0,33logMAR and mean CRT was 502±222,16µm. Mean BCVA was unchanged at the third day 0,74±0,38logMAR (P=0,5), improved to 0,62±0,32logMAR (p=0,02), 0,59±0,26logMAR (p=0,02), and 0,63±0,38logMAR (p=0,6) at the 1st, 3rd, and 4th month, respectively, and decreased to 0,73±0,35logMAR (p=0,4) at the 6th month follow-up. Mean CRT improved to 397±115,31µm (p=0,17), 271±99,97µm (p=0,007), 325±133,05µm (p=0,03) and 462±176,48µm (p=0,36) at the 3rd day and at the 1st, 3rd and 4th month of follow-up and then increased again to 537±265,42µm (p=0,33) at the 6th month.Two cases showed a CRT increase to a higher level than baseline (rebound effect) at the 6th month. Eight patients needed retreatments at the 6th month. No serious ocular and systemic adverse events were observed. One eye developed a transient IOP increase 1 month after injection, which was successfully managed with topical IOP-lowering medication. Cataract progression was not observed during this short study.
The DEX implant 0,7 mg produced improvement of BCVA and reduction of CRT from the first days after the injection and was maintained until the 3rd (in terms of CRT changes) or 4th month (in terms of BCVA changes). Ozurdex® was well tolerate in all patients. Large series and further follow-up are required to assess the efficacy in the long term.
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