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.

Authors

• Ingrid U Scott
• Michael S Ip
• Paul C VanVeldhuisen
• Neal L Oden
• Barbara A Blodi
• Marian Fisher
• Clement K Chan
• Victor H Gonzalez
• Lawrence J Singerman
• Michael Tolentino

Publication/Presentation Date

9-1-2009

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.

Volume

127

Issue

9

First Page

1115

Last Page

1128

ISSN

1538-3601

Published In/Presented At

Scott, I. U., Ip, M. S., VanVeldhuisen, P. C., Oden, N. L., Blodi, B. A., Fisher, M., Chan, C. K., Gonzalez, V. H., Singerman, L. J., Tolentino, M., & SCORE Study Research Group (2009). 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. Archives of ophthalmology (Chicago, Ill. : 1960), 127(9), 1115–1128. https://doi.org/10.1001/archophthalmol.2009.233

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

19752420

Department(s)

Administration and Leadership

Document Type

Article