PROSPECTIVE, RANDOMIZED CLINICAL TRIAL OF INTRAVITREAL TRIAMCINOLONE TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Abstract

To investigate the effect of intravitreal injection of high-dose (20-25 mg) triamcinolone acetonide on minimally classic or occult choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). A prospective, double-masked, placebo-controlled, randomized clinical trial included 39 eyes with minimally classic or occult CNV secondary to AMD. The treatment group (21 eyes) received intravitreal injection (20-25 mg) of triamcinolone acetonide and the control group (18 eyes) received intravitreal injection (500 mug) of dexamethasone at 6-month intervals. Best-corrected ETDRS (Early Treatment Diabetic Retinopathy Study) score, contrast sensitivity score, and central macular volume were measured at 1 month, 3 months, 6 months, and 12 months. Mean baseline best-corrected visual acuity (BCVA [logarithm of the minimal angle of resolution]) was 0.64 (Snellen equivalent, 20/80) in each group. At 1 month, 3 months, and 6 months after the injection, neither group had a significant change in BCVA. At 12 months, mean BCVA +/- SD significantly decreased to 1.06 +/- 0.34 (Snellen equivalent, 20/200) in the treatment group (paired t-test, P < 0.001), whereas it was 0.78 +/- 0.52 (Snellen equivalent, 20/125) in the control group (P = 0.23). The difference was marginally significant (P = 0.06, Student's t-test). All phakic eyes in the treatment group developed marked cataract progression. Intravitreal injection of high-dose triamcinolone had no beneficial effect on eyes with minimally classic or occult CNV secondary to AMD and was associated with outcomes similar to those associated with intravitreal injection of dexamethasone, which was used as placebo.