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M.C. Gillies, M. Zhu, J.M. Simpson, F.K. P. Sutter; A Randomized, Placebo–Controlled Trial of Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema That Persists or Recurs After Laser Treatment – 2–Year Results . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4672.
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To study the safety and efficacy of an intravitreal injection of triamcinolone acetonide (IVTA) for diabetic macular edema that persists or recurs after laser treatment.
Eyes were randomised to receive 4mg of IVTA or subconjunctival saline up to every 6 months with laser treatment if appropriate according to a prospectively identified treatment paradigm. The main outcome measures were improvement of best–corrected LogMAR visual acuity by 5 or more letters and incidence of moderate or severe adverse events.
69 eyes of 43 patients participated, with 34 eyes randomized to receive active treatment and 35 placebo. 64/69 (93%) eyes were still participating in the study when the data were analysed in September 2004, by which time 15 IVTA–treated eyes and 13 placebo–treated eyes had completed the 2–year study visit. Elevation of the intraocular pressure (IOP) by 5 or more mmHg was recorded in 21/33 (64%) IVTA–treated vs. 3/31 (9%) placebo–treated eyes. Trabeculectomy was required in 1/33 (3%) triamcinolone–treated eyes. Topical therapy was required and otherwise sufficient in 14/33 (42%) triamcinolone–treated vs. 1/31 (3%) placebo–treated eyes. Significant progression of cataract was noted in 12/33 (36%) IVTA–treated vs. 3/31 (9%) placebo–treated eyes. 13/33 (39%) IVTA–treated eyes underwent cataract surgery. One IVTA–treated eye developed infectious endophthalmitis which was adequately treated without loss of visual acuity.
The short term efficacy of intravitreal triamcinolone which we have previously reported for eyes with diabetic macular edema that have failed laser treatment appears to persist for up to 2 years with ongoing treatment as required. The safety profile of IVTA for diabetic macular edema is significant but appears to be manageable.
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