Publications (2)9.54 Total impact
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ABSTRACT: To report the 24 months outcomes from a clinical trial of intravitreal triamcinolone acetonide (IVTA) plus laser versus laser treatment only in eyes with diabetic macular edema (DME). Prospective, double-masked, randomized, placebo-controlled study. Eighty-four eyes of 54 participants were entered into the study, with 42 eyes randomly assigned to receive IVTA plus laser and 42 randomly assigned to receive laser treatment alone. Primary end point data were available for 71 (84.5%) eyes at 24 months, with last visual acuity observation carried forward for the remaining eyes. Best-corrected logarithm of minimum angle of resolution (logMAR) visual acuity and central macular thickness (CMT) by optical coherence tomography were measured after laser treatment preceded by either IVTA or sham. The primary outcome was the proportion of eyes with improvement in visual acuity of 10 letters or more at 24 months. The secondary outcomes were mean visual acuity, requirement for further treatment, change in CMT, and adverse events. At 24 months, improvement of 10 logMAR letters or more was seen in 15 (36%) of 42 eyes treated with IVTA plus laser compared with 7 (17%) of 42 eyes treated with laser only (P = 0.047; odds ratio, 2.79; 95% confidence interval, 1.01-7.67). There was no difference in the mean CMT or mean logMAR visual acuity between 2 groups. At least 1 retreatment was required in the second year of the study in 29 (69%) of 42 IVTA plus laser-treated eyes compared with 19 (45%) of 42 laser only eyes (P = 0.187). Cataracts were removed from 17 (61%) of 28 phakic IVTA plus laser-treated eyes versus 0 (0%) of 27 laser only eyes (P<0.001). Treatment for elevated intraocular pressure was required in 27 (64%) of 42 IVTA plus laser eyes compared with 10 (24%) of 42 laser only eyes (P<0.001). Treatment with IVTA plus laser resulted in a doubling of improvement in vision by 10 letters or more compared with laser only over 2 years in eyes with DME, but is associated with cataract and raised intraocular pressure.
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ABSTRACT: To determine whether pretreatment with intravitreal triamcinolone acetonide (IVTA) before laser photocoagulation is effective in eyes with diabetic macular edema (DME). The study was a prospective, double-masked, placebo-controlled, clinical trial of eyes with DME and impaired vision (<or=20/40) randomized to IVTA 4 mg versus placebo 6 weeks before laser treatment. The main outcome measure was the proportion of eyes with improvement of best-corrected logarithm of minimum angle of resolution (logMAR) visual acuity of >or=5 letters after 6 months. Secondary outcomes were necessity of further treatment, change in central macular thickness, and incidence of adverse events. Eighty-four eyes of 54 participants were entered into the study, with 6-month data available for 81 (96%) of 84 eyes. Improvement of >or=5 logMAR letters was similar in eyes treated with IVTA before laser as placebo (18/42 [43%] IVTA vs. 16/34 [38%] laser alone; P = 0.807), as were retreatment rates at 6 months (22 [56%] IVTA vs. 21 [53%] laser alone; P = 0.727). Mean central macular thickness decreased by 50 microm (95% confidence interval, 10-96 microm) more in the IVTA treatment group than in the laser-alone group after 6 months (P = 0.016). Glaucoma therapy was necessary more frequently in IVTA-treated eyes than in those treated with laser alone (19/42 [45%] vs. 7/42 [17%]; P = 0.005). Visual results and the need for further laser treatment at 6 months were no better in the IVTA group than in the laser-alone group, despite a better anatomic outcome reflected by reduction in mean central macular thickness. This study found no evidence of a synergistic effect of IVTA and laser photocoagulation for DME. (ClinicalTrials.gov number, NCT00148265).
University of Melbourne
Melbourne, Victoria, Australia
- Centre for Eye Research Australia