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One-Year Results

Mark C. Gillies, FRANZCO, PhD; Judy M. Simpson, PhD; Wei Luo, MPH; Philip Penfold, PhD; Alex B. L. Hunyor, FRANZCO; William Chua, FRANZCO; Paul Mitchell, FRANZO, PhD; Frank Billson, FRANZCO

Arch Ophthalmol. 2003;121:667-673.

Objective  To determine if a single intravitreal injection of 4 mg of triamcinolone acetonide in patients with classic choroidal neovascularization associated with age-related macular degeneration can safely reduce the risk of severe visual loss.

Methods  A double-masked, placebo-controlled, randomized clinical trial was performed in patients 60 years or older who had choroidal neovascularization with any classic component, a duration of symptoms of less than 1 year, and a visual acuity of 20/200 or better. Best-corrected visual acuity, intraocular pressure, and cataract grading were performed before the injection and then at 3, 6, and 12 months.

Main Outcome Measure  The development of severe loss of vision (30 letters) by survival analysis on an intention-to-treat basis.

Results  One hundred fifty-one eyes were randomized into the study, and follow-up data were obtained for 73 (97%) of the 75 eyes in the treated group and for 70 (92%) of the 76 eyes in the control group. There was no difference between the 2 groups for the development of severe visual loss during the first year of the study (log-rank ²₁ = 0.03, P = .90). In both groups, the 12-month risk of severe visual loss was 35%, with a hazard ratio of 1.05 (95% confidence interval, 0.59-1.86). The change in size of the neovascular membranes, however, wassignificantly less in eyes receiving triamcinolone thanin those receiving placebo 3 months after treatment (P = .01), although no difference was noted after 12 months. After 12 months, treated eyes had a significantly higher risk of an elevated intraocular pressure (31/75 [41%] vs 3/76 [4%]; P<.001), but not of cataract progression (P = .29).

Conclusions  A single dose of intravitreal triamcinolone had no effect on the risk of loss of visual acuity during the first year of the study in eyes with age-related macular degeneration and classic choroidal neovascularization, despite a significant antiangiogenic effect found 3 months after treatment. This biological effect warrants further study.

From the Save Sight and Eye Health Institute (Drs Gillies, Penfold, Chua, Mitchell, and Billson and Ms Luo), and the Departments of Clinical Ophthalmology (Drs Gillies, Penfold, Chua, Mitchell, and Billson and Ms Luo) and Public Health and Community Medicine (Dr Simpson), University of Sydney; and the Retina Unit, Sydney Eye Hospital (Dr Hunyor), Sydney, Australia. Drs Gillies, Penfold, and Billson are listed as inventors on patents that cover the use of intraocular steroids to treat retinal neovascularization. All other authors have no relevant financial interest in this article.

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