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M.C. Gillies, F.K. Sutter; Interim (3 month) Analysis of the Efficacy of Intravitreal Triamcinolone for Diabetic Macular Oedema that Persists after Laser Treatment. A Randomized Clinical Trial: TDMO . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3219.
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Purpose:Whilst there are several uncontrolled studies reporting a beneficial effect of triamcinolone for diabetic macular oedema, to date there have been no data from randomized clinical trials. We report the interim (3 month) efficacy data from a study of intravitreal triamcinolone acetonide (4mg)in eyes with diabetic cystic foveal oedema that persists after adequate macular laser.Methods:A double-masked, placebo-controlled, randomized clinical trial is underway at a tertiary referral public hospital. Eligibility criteria included diabetic cystic foveal oedema in one or both eyes which persists longer than 3 months after adequate macular photocoagulation and best corrected visual acuity in the affected eye(s) 6/9 or worse. Best corrected visual acuity was recorded using LogMAR charts before treatment and at one and three months. The primary outcome measures were (i) the improvement of best corrected visual acuity by 5 or more letters and (ii) the development of moderate or severe adverse events. Secondary outcomes included change in macular thickness as determined by OCT and contact lens examination. Results were analyzed on an intention to treat basis. Results:31 eyes in 21 patients have completed the three 3 follow-up, 10 with both eyes and 11 with only one eye in the study. 9/16(56.3%) eyes treated with triamcinolone gained five or more letters of best corrected visual acuity compared to 2/15 (13%) eyes treated with placebo (chi square 4.5, p=0.023). Only 1/16 (6%) treated eyes lost five or more letters compared with 5/15 (33%) untreated eyes . OCT and biomicroscopy showed significant reduction of macular oedema in the treatment group. There were no moderate or severe complications related to treatment.Conclusions:These data sugests that, in the short term, intravitreal triamcinolone reduces the risk of progressive loss of vision and commonly improves vision in patients with diabetic cystoid foveal oedema that persists after adequate laser treatment. Furthermore the treatment significantly reduces macular thickness in these eyes. However, it is not yet known how long this beneficial effect persists, whether multiple injections continue to be efficacious and whether there are adverse events associated with long term treatment. Therefore we do not recommend this treatment outside properly conducted clinical trials until long term safety and efficacy data is available.
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