Session Title: Vascular Diseases and Diabetic Retinopathy
Session Date/Time: Friday 18/09/2015 | 11:00-12:30
Paper Time: 11:24
First Author: : P.Lanzetta ITALY
Co Author(s): :
PURPOSE:Additional treatment options are needed for patients with diabetic macular edema (DME) who fail to achieve significant improvement in visual acuity with prior treatment for DME. Therefore, we sought to examine the efficacy and safety of dexamethasone intravitreal implant (DEX) 0.7 mg treatment in patients with previously treated DME. The purpose of this study is to evaluate DEX 0.7 mg treatment in a subset of Mead study, DME patients that were previously treated with laser and/or medical therapy.
The subgroup analysis used pooled data from two randomized, multicenter, masked, sham-controlled, 3-year, phase III clinical trials using identical protocols that evaluated the safety and efficacy of DEX 0.7 mg for treatment of DME. The trials were conducted at 131 sites in 22 countries from February 2005 to June 2012.
Three-year, randomized, sham-controlled phase III study. Patients with DME were randomized to DEX 0.7 mg, DEX 0.35 mg, or sham procedure with retreatment no more than every 6 months. Subgroup analysis evaluated outcomes in patients who had or had not received prior treatment for DME at study entry. Outcome measures included ≥15-letter gain in best-corrected visual acuity (BCVA) at study end (ITT-LOCF analysis), average change in BCVA and central retinal thickness (CRT) from baseline during the study (area-under-the-curve approach), and adverse events.
Overall, 72.2% (757/1048) of patients had previously treated DME. Baseline characteristics of previously treated DEX 0.7 mg (n=247) and sham (n=261) patients were similar. In the previously treated subgroup, mean treatments numbers over 3 years were 4.1 for DEX 0.7 mg and 3.2 mg for sham, 21.5% of DEX 0.7 mg patients vs. 11.1% of sham had ≥15-letter BCVA gain from baseline at study end (P-value equals 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 mg vs. +1.5 letters with sham (P-value equals 0.024), and mean average CRT change from baseline was -126.1 µm with DEX 0.7 mg vs. –39.0 µm with sham (P-value less than 0.001). In the smaller subset of treatment-naïve patients (too small for statistical significance), 24.0% (25/104) of DEX 0.7 mg patients vs. 14.6% (13/89) of sham had ≥15-letter BCVA gain from baseline at study end (P-value equals 0.096). Cataract-related adverse events were reported in 70.3% of baseline phakic patients in the previously treated DEX 0.7 mg subgroup; vision gains were restored following cataract surgery.
DEX 0.7 mg significantly improved visual and anatomic outcomes in a DME patient subset previously treated with laser, intravitreal anti-VEGF, intravitreal steroid, or a combination of these therapies with a safety profile similar to the total study population. The data suggest that the DEX implant may have a role in the treatment of DME in a substantial number of patients who fail to respond to standard therapy.