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Riccardo Sacconi, Maurizio Battaglia Parodi, Stefano Casati, Rosangela Lattanzio, Francesco Bandello, Giorgio Marchini; Dexamethasone implant in diabetic macular edema patients with high visual acuity. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3274.
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© ARVO (1962-2015); The Authors (2016-present)
Intravitreal dexamenthasone implant was shown to be effective in the management of diabetic macular edema (DME). We performed an interventional prospective clinical study to evaluate in detail the effects of intravitreal dexamethasone implant in patients affected by DME with high best corrected visual acuity (BCVA) over a one-year follow-up.
Ten eyes (10 patients) affected by DME with BCVA of 0.3 to 0.0 LogMAR and central foveal thickness (CFT) > 300 µm were enrolled into the study. Exclusion criteria were: presence of any other ocular disorder able to confound the clinical assessment, diagnosis of glaucoma, presence of media opacities, and treatment with intravitreal anti-VEGF within 3 months of baseline. All patients underwent a complete ophthalmologic examination, including BCVA on standard ETDRS charts, fluorescein angiography and spectral-domain OCT. Dexamethasone 700-µg implant was administered at baseline. All patients were revaluated every 45 days with a new completed ophthalmologic examination and spectral-domain OCT. Retreatments were carried out on a pro-re-nata basis if DME was still present at OCT scans. Primary outcome measures included changes in BCVA and CFT. Secondary outcomes included the number of implants, re-treatment interval, and incidence of side effects. The Student paired t-test was used to evaluate the changes in BCVA and CFT, and the 95% confidence interval was provided.
Mean baseline BCVA was 0.22±0.09 LogMAR, and improved to 0.06±0.07 LogMAR at the end of the follow-up (p=0.001). Mean central foveal thickness changed from 532±113 µm to 306±57 µm (p<0.001). The mean number of implants was 1.90±0.57. Retreatment was necessary after mean of 6.9±1.6 months from the baseline (7 of 10 eyes), and after 4 months from the second implant in the only eye that has required a third implant. No serious adverse events were observed. Two eyes developed a transient IOP increase (mean 25.0±1.0 mmHg), which was successfully managed with topical IOP lowering medication.
Dexamethasone implant on a pro-re-nata basis with a variable retreatment interval can be considered a beneficial approach in the treatment of DME patients with high visual acuity over a one-year follow-up. Further studies are warranted to confirm our results.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
OCT scans of the same case: [A] Baseline (BCVA 0.3 LogMAR) [B] 12-month examination, after 2 Dexamethasone implants (BCVA 0.0 LogMAR)
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