Intravitreal triamcinolone prior to laser treatment of diabetic macular edema:
24-month results of a randomized controlled trial.
Author(s): Gillies MC, McAllister IL, Zhu M, Wong W, Louis D, Arnold JJ, Wong TY.
Affiliation(s): Save Sight Institute, the University of Sydney, Sydney, Australia.
mark@eye.usyd.edu.au
Publication date & source: 2011, Ophthalmology. , 118(5):866-72
PURPOSE: 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).
DESIGN: Prospective, double-masked, randomized, placebo-controlled study.
PARTICIPANTS: 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.
METHODS: 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.
MAIN OUTCOMES MEASURES: 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.
RESULTS: 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).
CONCLUSIONS: 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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