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Gina Hong, Gabriel M Gordon, Dante Joseph Pieramici; Dexamethasone Intravitreal Implant versus Intravitreal Anti-VEGF for the Treatment of Persistent Diabetic Macular Edema, Six Month Interim Study Analysis (DIME Study). Invest. Ophthalmol. Vis. Sci. 2018;59(9):4837.
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Long-term corticosteroid implants, such as Ozurdex, have become an alternative treatment to monthly intravitreal injections of anti-VEGF for persistent diabetic macular edema (pDME). Whether these treatments are as effective as monthly anti-VEGF treatments is uncertain. The purpose of this initial assessment is to compare the CST and BCVA levels in patients with pDME from baseline to six months to determine whether Ozurdex is non-inferior to monthly anti-VEGF.
Overall, 40 eyes from 40 subjects with pDME were enrolled prospectively. Data was analyzed for subjects who completed their 6-month visit, n=8 for the anti-VEGF group and n=12 for the Ozurdex group. All subjects received anti-VEGF monthly for 3 months. At month 3, central subfield thickness (CST) was compared to baseline CST values, and subjects with any increase in CST or <10% reduction and CST remained >300 μm or reduction in CST but remained >350 μm were randomized 1:1 to receive Ozurdex or continue on anti-VEGF; if not, they were exited from the study. Over the course of 6 months, the anti-VEGF arm got 6 injections compared to 4 injections for the Ozurdex arm. At month 6, if subjects in anti-VEGF group continued to demonstrate pDME (<10% reduction or any increase in CST compared to baseline values and CST is >300 μm), they were given Ozurdex.
Baseline mean CST for the anti-VEGF and Ozurdex arms were 461 and 441 μm respectively. At 6 months the mean CST remained virtually unchanged in the anti-VEGF group at 460 μm (p=0.99). At 6 months, the mean CST in the Ozurdex group was 423 μm (p=.58). Baseline mean BCVA for anti-VEGF and Ozurdex arms were 60 and 58 letters respectively. At 6 months, the mean BCVA improved to 63 in the anti-VEGF group (p=0.18) and remained virtually stable at 57 letters in the Ozurdex group (p=0.8). 6 of the 8 subjects (75%) in the anti-VEGF arm met criteria to switch to Ozurdex at month 6.
These results indicate that patients receiving Ozurdex for pDME may expect similar anatomic and visual outcomes with reduced treatment and financial burden compared to a strict monthly anti-VEGF protocol.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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