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M. C. Gillies; Intravitreal Triamcinolone for Refractory Diabetic Macular Oedema: 5-Year Results of a Double-Masked, Placebo-Controlled, Randomised Clinical Trial With Open Label Extension. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1565.
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To report the results of a preliminary analysis of 5-year safety and efficacy outcomes from a 2-year double-masked, placebo-controlled, randomised clinical trial with 3 year open-label extension of intravitreal triamcinolone acetonide (IVTA) injections (4mg) in eyes with refractory diabetic macular edema.
69 eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment and 35 placebo. Five-year data were available for 52/69 (75%) eyes of 33/41 (80%) patients. Eyes randomized to initial placebo received a subconjunctival injection of saline. After 2 years, all patients, including those initially randomized to placebo, received treatment with IVTA if there was persistent impairment of vision with central macular thickness (CMT) > 275 micron. Main outcome measures were Improvement of best-corrected LogMAR (Logarithm of Minimum Angle of Resolution) visual acuity by 5 or more letters and incidence of moderate or severe adverse events. Data from eyes with missing 5 year data were treated as Last Observation Carried Forward.
During the third year or the study when all eyes were eligible for treatment, a similar proportion of eyes from the 2 groups had macular edema with persistent impairment of vision that warranted further treatment with IVTA: initial-IVTA, 12/29 (41%); initial-placebo, 10/28 (36%). The mean visual acuity score at baseline was 59.2 and at 5 years 62.8 letters in the initial-IVTA group. The mean visual acuity score at baseline was 59.7 and 58.3 at 5 years in the initial placebo group. The mean reduction in CMT was 76 micron in the initial-IVTA group compared with 186 micron in the initial-placebo group. Glaucoma medication was required at some point in 23/26 (88%) initial-IVTA vs 5/26 (19%) initial-placebo eyes. Cataract surgery was performed in 19/26 (73%) initial-IVTA vs 2/26 (8%) initial-placebo eyes. 3 eyes in the initial-IVTA group required trabeculectomy. There was one case of infectious endophthalmitis in the initial-IVTA group.
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