Intravitreal Triamcinolone for Refractory Diabetic Macular Edema: Two-Year Results of a Double-Masked, Placebo-Controlled, Randomized Clinical Trial
Presented in part at: Association for Research in Vision and Ophthalmology meeting, May 2005, Fort Lauderdale, Florida.
Received 14 October 2005; accepted 2 February 2006. published online 06 July 2006.
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.
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.
Intervention
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.
Main Outcome Measures
Improvement of best-corrected logarithm of the minimum angle of resolution visual acuity (VA) by ≥5 letters after 2 years and incidence of moderate or severe adverse events.
Results
Improvement of ≥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 (zgeneralized 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 ≥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.
Conclusion
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.
1Save Sight Institute, Department of Clinical Ophthalmology and Eye Health, University of Sydney, Sydney, Australia.
2School of Public Health, University of Sydney, Sydney, Australia.
Correspondence to A/Prof Mark Gillies, Save Sight and Eye Health Institute, Department of Clinical Ophthalmology, University of Sydney, GPO Box 4337, Sydney NSW 2001, Australia.
Manuscript no. 2005-994.
This study was funded by grants from the Sydney Eye Hospital Foundation, Sydney, Australia; Ophthalmic Research Institute of Australia, Surry Hills, Australia; Juvenile Diabetes Research Foundation, New York, New York; and Diabetes Australia Research Trust, Canberra, Australia. The study was investigator initiated and unsupported by the pharmaceutical industry.
2 Dr Gillies is included as an inventor on patents relating to the formulation of triamcinolone for ocular use and its use for the treatment of retinal neovascularization but not macular edema.
3 Drs Sutter, Simpson, and Larsson; Ms Ali; and Dr Zhu have no conflicting or proprietary interests.
ABSTRACT