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F.K. Sutter, M.C. Gillies; Interim (3 month) Analysis of the Safety of Intravitreal Triamcinolone for Diabetic Macular Oedema that Persists after Laser Treatment. Results from a Randomized Clinical Trial: TDMO . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4003.
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Purpose: Several uncontrolled series of patients have been presented in whom intravitreal triamcinolone acetonide appeared to be effective for diabetic macular oedema. The safety of this invasive treatment, however, has not been reported in this patient group. We report the interim (3 month) safety data of intravitreal triamcinolone acetonide (4mg) in patients with diabetic cystic macular oedema that persists after adequate macular laser. Methods: A double-masked, placebo-controlled, randomized clinical trial is underway at a tertiary referral public hospital. Patients with cystic diabetic foveal oedema in one or both eyes which persisted longer than 3 months after adequate macular photocoagulation and best corrected visual acuity in the affected eye(s) 6/9 or worse were included. Results: 31 eyes in 21 patients have completed the three 3 month study visit, 10 patients with both eyes and 11 with only one eye in the study. One patient passed away 10 weeks after baseline treatment due to acute congestive heart failure. Another patient suffered from an ischemic stroke 5 months after entry into the study. These events were judged not to be related to treatment. Otherwise there were no moderate or severe adverse events associated with treatment. 4/16 (25%) treated eyes developed elevated intraocular pressure (IOP) of five or more mmHg one month after treatment compared to 1/15 (6.6%) untreated eyes. Increased IOP was controlled with topical medication in all cases. In the phakic eyes in the study, masked cataract grading showed an increase of nuclear sclerosis by one grade in 3/14 (21.4%) treated eyes and increase of posterior subcapsular cataract by one grade in 2/14 (14.3%) treated eyes compared to 3/12 (25%) and 0/12 (0%) respectively in the placebo group. Conclusions: These data suggest that intravitreal triamcinolone has a significant but manageable adverse event profile in eyes with diabetic retinopathy. However, it is not yet known whether there will be adverse events associated with long term treatment. Therefore we do not recommend this treatment outside properly conducted clinical trials until long term safety data is available.
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