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David Callanan, Sunil Gupta, Thomas A. Ciulla, David S. Boyer, Ching-Chi Liu, Jean Lou, Xiao-Yan Li, Scott M. Whitcup; Efficacy and Safety of Combination Therapy with Dexamethasone Intravitreal Implant (DEX Implant) Plus Laser Photocoagulation Versus Monotherapy With Laser for Treatment of Diffuse Diabetic Macular Edema (DDME). Invest. Ophthalmol. Vis. Sci. 2011;52(14):3968.
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To compare the efficacy and safety of DEX implant plus laser versus laser alone for treatment of DDME.
This double-masked study randomized (1:1) DDME patients with central retinal thickness (CRT) of ≥ 275 µm and BCVA of ≥ 34 to ≤ 70 letters to receive DEX implant at day 0 followed by laser photocoagulation at month 1 (n = 126) or laser alone at month 1 (n = 127). If needed, patients were retreated with DEX implant at month 6 or 9 and with laser at months 4, 7, and 10. The primary outcome was the proportion of patients with a BCVA improvement of ≥ 10 letters from baseline at month 12. The efficacy outcomes were reported for 99 combination patients and 101 laser patients with confirmed diffuse edema at baseline.
At month 12, the proportion of patients with ≥ 10-letter improvement from baseline BCVA was 28% in the combination group and 24% in the laser group (P = .453). The number of additional treatments was similar in both groups, with approximately 1.6 DEX implants and 2.2 laser treatments administered per patients. Compared to the laser alone, patients treated with the combination therapy had significantly higher mean increases from baseline BCVA at months 1, 4, 6, 7, and 9 (P < .05), significantly greater mean reductions from baseline CRT at months 1 and 6 (P < .001), and significantly higher mean decreases from baseline diffuse leakage area in months 4, 6, 9, and 12 (P < .05). Elevation of intraocular pressure (IOP) was the only adverse event that occurred significantly more in the combination group (25/125 [20%]; P < .001) than the laser group (2/127 [1.6%]), with, respectively, 1% and 0% of patients having ≥ 10 mm Hg increase from baseline IOP at month 12.
DEX implant plus laser was well tolerated and improved BCVA, CRT, and leakage area more than laser alone in DDME patients.
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