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T. Y. Wong, I. L. McAllister, M. Zhu, W. Wong, D. Louis, J. J. Arnold, M. C. Gillies; Intravitreal Triamcinolone and Laser versus Laser Alone for Treatment of Diabetic Macular Edema: 24-Month Results of a Mult-Center, Prospective, Randomized Controlled Trial. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6425.
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To report the 24 months outcomes from a prospective, double-masked, placebo-controlled randomized clinical trial of intravitreal triamcinolone acetonide (IVTA) 4mg plus laser versus laser treatment only in eyes with diabetic macular edema (DME) to determine whether there may be a synergistic effect between the two treatments.
84 eyes of 54 participants were entered into the study, with 42 eyes randomly assigned to receive IVTA and 42 to placebo 6 weeks prior to standard laser treatment. Further laser was applied according to prospectively defined criteria. 24 months primary endpoint data were available for 71 (84.5%) eyes; with last visual acuity observation carried forward for remainder 13 eyes. The primary outcome was the proportion of eyes with improvement of best-corrected Logarithm of Minimum Angle of Resolution (LogMAR) visual acuity of 10 letters or greater at 24 months. Secondary outcomes were mean visual acuity levels, requirement for further treatment, change in central macular thickness (CMT) on OCT measurements, and incidence of adverse events.
The two groups were well matched for patient and ocular characteristics at baseline. At 24 months, improvement of 10 LogMAR letters or greater was found in 15/42 (36%) eyes treated with IVTA plus laser compared with 7/42 (17%) eyes treated with laser only (p=0.047, GEE logistic regression). At 24 months, the mean CMT was 346.8µm ± 114.9SD and 372.6µm ± 154.2SD comparing IVTA plus laser versus laser only (p=0.349) and mean logMAR visual acuity was 56.1 ± 15.7SD letters and 54.5 ± 16.1SD comparing IVTA plus laser versus laser only. (p=0.439). Six eyes (14%) in the IVTA plus laser group needed re-treatment at 24 months, compared to three (7%) for placebo (P = 0.48, Fisher’s exact test). Adverse events at 24 months related to treatment were observed for eight eyes from IVTA plus laser and one eye from the laser only group.
Over 2 years, IVTA plus laser resulted in a doubling of improvement in vision by 10 letters or greater as compared to laser only in eyes with DME. This suggests IVTA combined with laser may be more effective than laser alone for the management of DME.
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