A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6

Abstract

Objective: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with standard care (grid photocoagulation in eyes without dense macular hemorrhage and deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage) for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO).

Methods: Multicenter, randomized clinical trial of 411 participants. Main Outcome Measure Gain in visual acuity letter score of 15 or more from baseline to month 12.

Results: Twenty-nine percent, 26%, and 27% of participants achieved the primary outcome in the standard care, 1-mg, and 4-mg groups, respectively. None of the pairwise comparisons between the 3 groups was statistically significant at month 12. The rates of elevated intraocular pressure and cataract were similar for the standard care and 1-mg groups, but higher in the 4-mg group.

Conclusions: There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group. Application to Clinical Practice Grid photocoagulation as applied in the SCORE Study remains the standard care for patients with vision loss associated with macular edema secondary to BRVO who have characteristics similar to participants in the SCORE-BRVO trial. Grid photocoagulation should remain the benchmark against which other treatments are compared in clinical trials for eyes with vision loss associated with macular edema secondary to BRVO. Trial Registration clinicaltrials.gov Identifier: NCT00105027.

Figures

Figure 1

Flowchart of participants in the Standard Care vs Corticosteroid for Retinal Vein Occlusion–Branch Retinal Vein Occlusion 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 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. Error bars represent upper 95% confidence limits. C, Box plot with whiskers representing the fifth and 95th percentiles; the line in the box represents the median; dots, values outside the whiskers; SC, standard care; 1 mg and 4 mg, doses of intravitreal triamcinolone acetonide.

Figure 2

Change from baseline in electronic Early Treatment Diabetic Retinopathy Study visual acuity 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. Error bars represent upper 95% confidence limits. C, Box plot with whiskers representing the fifth and 95th percentiles; the line in the box represents the median; dots, values outside the whiskers; SC, standard care; 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 thickness smaller than 250 μm (A) and larger than 500 μm (B) throughout follow-up. Error bars represent upper 95% confidence limits. C, Box plots, with whiskers representing the fifth and 95th percentiles; the line in the box represents the median; dots, values outside the whiskers; SC, standard care; 1 mg and 4 mg, doses of intravitreal triamcinolone acetonide. Horizontal reference lines at 250 and 500 μm are presented.

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 thickness smaller than 250 μm (A) and larger than 500 μm (B) throughout follow-up. Error bars represent upper 95% confidence limits. C, Box plots, with whiskers representing the fifth and 95th percentiles; the line in the box represents the median; dots, values outside the whiskers; SC, standard care; 1 mg and 4 mg, doses of intravitreal triamcinolone acetonide. Horizontal reference lines at 250 and 500 μm are presented.