A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5

Abstract

Objective: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO).

Methods: Multicenter, randomized, clinical trial of 271 participants.

Main outcome measure: Gain in visual acuity letter score of 15 or more from baseline to month 12.

Results: Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group.

Conclusions: Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

Figure 1

Flowchart of participant progress in the SCORE-CRVO Study. Missed visits include those who missed a visit but came back for other visits and those who prematurely withdrew from the study.

Figure 2

Change from baseline in electronic Early Treatment Diabetic Retinopathy Study visual acuity letter score at each 4-month follow-up visit. The histograms show the percentages of participants with a gain (A) or loss (B) in visual acuity letter score of 15 or more from baseline. The dashed line from each bar represents the upper 95% confidence limit. C, Box plot with whiskers represents the 5th and 95th percentiles; the line in the box represents the median; dots, values outside the whiskers; O, observation; 1 mg and 4 mg, doses of intravitreal triamcinolone acetonide.

Figure 3

Optical coherence tomography–measured center point thickness at each 4-month follow-up visit. The histograms show the percentages of participants with center point thicknesses of less than 250 μm (A) and greater than 500 μm (B). The line from each bar represents the upper 95% confidence limit. C, Box plots with whiskers represent the 5th and 95th percentiles; the line in the box represents the median; dots, values outside the whiskers; O,observation; 1 mg and 4 mg, doses of intravitreal triamcinolone acetonide. Horizontal reference lines at 250 and 500 μm are presented.