Abstract
Purpose :
The purpose of this research study is to compare the effectiveness of using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for subjects with persistent diabetic macular edema (pDME).
Methods :
Forty subjects with pDME were enrolled and received anti-VEGF injections (IVT) during a 3-month run-in phase to confirm pDME. At month 3 (baseline), patients with <10% reduction in CST compared to baseline were randomized 1:1 to receive Ozurdex (OZ, n=15) every 3 months or IVT (n=15) monthly. If patients in the IVT arm had 6 injections and continued to present with <10% reduction in CST compared to baseline, they had the option to receive the OZ implant at Month 6 or later.
Results :
Study retention rate through 12 months was 75%. While there was a significant difference in BCVA at baseline, BCVA was not significantly different between arms at any other time. Average CST was significantly reduced in the OZ arm only at months 4 (337 vs 406μm, p=0.02) and 5 (239 vs 417μm,p=0.01) compared to the IVT arm. At months 6 or 12, there was no significant difference in CST (p=0.81 and 0.97, respectively) or BCVA (p=0.18 and 0.79, respectively) outcomes between arms. For 2 months following their initial OZ treatment, subjects in the OZ arm saw a significant improvement in CST (p<0.001 for both) and BCVA (p<0.001 and p=0.03) compared to baseline; CST was also significantly improved for 2 months following their second OZ treatment (p<0.01 for both). Compared to baseline, the IVT arm never showed a significant improvement in BCVA; CST was significantly improved at months 7-10 (p=0.005, 0.006, 0.014, and 0.0004, respectively).
Conclusions :
In this study, switching patients who were unresponsive following IVT therapy to OZ led to a temporary improvement in edema and vision compared to continuing with IVT monotherapy. This study was not designed to determine if long term switching to OZ is superior to continued IVT or combination therapy; further studies are required.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.