First Author: L.Toto ITALY
Co Author(s): L. Di Antonio P.A. Mattei A. Mastrocola C. De Nicola A. Mastropasqua L. Mastropasqua 0 0 0 0 0 0 0 0 0
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To evaluate the efficacy and safety of dexamethasone 0.7 mg intravitreal Dexamethasone implants (DEXi; Ozurdex®; Allergan Inc, Irvine, CA) in patients with treatment naïve diabetic macular edema (DME).
Ophtahlmology Clinic, Department of Science of Ageing, University “G. d’Annunzio” of Chieti-Pescara.
In this prospective interventional study twenty eyes of twenty patients (12 males, 8 female; mean age 68.7±10.3 years) with DME underwent DEXi (0.7 mg). The main outcome measures were best corrected visual acuity (BCVA), optical coherence tomography central retinal thickness (CRT), macular retinal sensitivity (MRS) within 8° by means of MP-1 microperimetry, multifocal electroretinography (mf ERG) within 30° using ring analysis strategy and pattern ERG (pERG) with amplitude and latency analysis of P50 and N95. All patients underwent monthly follow-up visits. The number of eyes requiring reinjections was also assessed. Adverse events and intraocular pressure (IOP) modifications were considered for safety evaluation.
At baseline mean BCVA was 0.41±0.38 logMAR and mean CRT was 493.4±193.4 µm. At the fourth month of follow up mean BCVA improved to 0.22 ±0.27 logMAR and CRT decreased to 275.2 ±41.6 (p<0.01). All patients underwent at least five-months of follow-up. MRS, mfERG and PERG showed a trend toward improvement from baseline to the fourth month of follow up. Functional and morphological parameters worsened at the fifth month of follow up with mean BCVA decreasing to 0.29 ±0.33 logMAR and CRT increasing to 380.78 ±167.36 µm. 60% of eyes were retreated after the fifth month of follow up. One month after retreatment there was a reduction of mean CRT to 286.71 ±143.18 µm with an increase of BCVA to 0.27±0.30 logMAR. Only two (10%) patients showed a transient increase of IOP during the follow up successfully managed with topical drugs.
DEXi is a promising alternative and effective treatment of DME in naïve eyes leading to significant improvements in both macular morphology and function. Such improvements were maintained until the fourth month of follow up with an acceptable safety profile.