Abstract
Purpose:
To assess anatomic outcomes with dexamethasone intravitreal implant [DEX implant] (Ozurdex®, Allergan Inc., Irvine, CA) 0.7 and 0.35 mg in the treatment of diabetic macular edema (DME).
Methods:
Two multicenter, randomized, sham-controlled Phase 3 trials of DEX implant (NCT00168337 and NCT00168389), with identical protocols, were conducted and data were pooled for analysis. Patients with DME, best-corrected visual acuity (BCVA) of 34 - 68 letters (20/200 - 20/50 Snellen equivalent), and retinal thickness in the 1-mm central subfield (CRT) ≥300 µm were randomized to treatment with DME implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years. Study visits occurred at 6-week (Year 1) and 3-month (Years 2 and 3) intervals; retreatment was permitted at ≥6-month intervals. Time-domain optical coherence tomography and fundus photography images were evaluated by a central reading facility.
Results:
The study eye of 1048 patients (mean age 62.4 years) received (mean) 4.1, 4.4, and 3.3 treatments with DEX 0.7 mg implant, DEX 0.35 mg implant, and sham, respectively, over 3 years. At all time points DEX 0.7mg and 0.35 mg implant reduced CRT (mean change from baseline to study end: -117.3 and -127.8 µm, respectively; mean average change [area-under-curve approach] over study period: -111.6 and -107.9 µm, respectively; all P<0.001 vs sham), and reduced macular volume (mean change from baseline to study end: -1.06 and -1.14 mm3, respectively; both P<0.001 vs sham). DEX 0.7 mg and 0.35 mg implant reduced disc areas of macular thickening on color photographs (mean change from baseline to study end: -2.753 and -2.931, respectively; both P<0.001 vs sham). More DEX 0.7mg and 0.35 mg implant- than sham-treated eyes showed improvement in clinically significant macular edema (retinal thickening ≥1 disc area, part ≤1 disc diameter from center, or retinal thickening or adjacent hard exudates ≤500 μm from center) (20.4% and 22.4%, respectively, vs 12.4% at study end; both P<0.05 vs sham). DEX 0.7mg implant reduced the risk in time to 2-step worsening in Diabetic Retinopathy Severity Score by 44% over the study period (P=0.03 vs sham).
Conclusions:
DEX 0.7 mg or 0.35 mg implant, administered at ≥6-month intervals over 3 years, provided rapid and sustained improvement in retinal thickening and delayed progression of retinopathy in patients with DME.
Keywords: 550 imaging/image analysis: clinical •
487 corticosteroids •
499 diabetic retinopathy