Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial.
OBJECTIVE
To report 2-year safety and efficacy outcomes from a trial of intravitreal triamcinolone acetonide (TA) injections (4 mg) in eyes with diabetic macular edema and impaired vision that persisted or recurred after laser treatment.


METHODS
Prospective, double-masked, placebo-controlled, randomized clinical trial.


METHODS
Sixty-nine eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment and 35 placebo. Two-year data were available for 60 of 69 (87%) eyes of 35 of 41 (85%) patients; 9 eyes of 6 patients were lost to follow-up, of which 6 received a placebo and 3 received intravitreal TA.


METHODS
Triamcinolone acetonide (0.1 ml) was injected through the pars plana using a 27-gauge needle. Eyes randomized to placebo received a subconjunctival injection of saline.


METHODS
Improvement of best-corrected logarithm of the minimum angle of resolution visual acuity (VA) by > or =5 letters after 2 years and incidence of moderate or severe adverse events.


RESULTS
Improvement of > or =5 letters' best-corrected VA was found in 19 of 34 (56%) eyes treated with intravitreal TA, compared with 9 of 35 (26%) eyes treated with the placebo (z(generalized estimating equation) = 2.73, P = 0.006). The mean improvement in VA was 5.7 letters (95% confidence interval, 1.4-9.9) more in the intravitreal TA-treated eyes than in those treated with the placebo. An increase of intraocular pressure (IOP) of > or =5 mmHg was observed in 23 of 34 (68%) treated versus 3 of 30 (10%) untreated eyes (P<0.0001). Glaucoma medication was required in 15 of 34 (44%) treated versus 1 of 30 (3%) untreated eyes (P = 0.0002). Cataract surgery was performed in 15 of 28 (54%) treated versus 0 of 21 (0%) untreated eyes (P<0.0001). Two eyes in the intravitreal TA-treated group required trabeculectomy. There was one case of infectious endophthalmitis in the treatment group.


CONCLUSIONS
Intravitreal TA improves vision and reduces macular thickness in eyes with refractory diabetic macular edema. This beneficial effect persists for up to 2 years with repeated treatment. Progression of cataract and elevation of IOP commonly occur but appear manageable. Spontaneous improvement over years can still occur in eyes that are apparently severely affected by diabetic macular edema.
Gillies
Mark C
MC
Save Sight Institute, Department of Clinical Ophthalmology and Eye Health, University of Sydney, Sydney, Australia. mark@eye.usyd.edu.au
Sutter
Florian K P
FK
Simpson
Judy M
JM
Larsson
Jorgen
J
Ali
Haipha
H
Zhu
Meidong
M
D000368:Aged; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007267:Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012160:Retina / Q000187:drug effects / Q000473:pathology; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000009:adverse effects / Q000627:therapeutic use*; D014792:Visual Acuity; D014822:Vitreous Body
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide