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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. Arch Ophthalmol 2009 Sep;127(9):1101-14

Date

09/16/2009

Pubmed ID

19752419

Pubmed Central ID

PMC2872173

DOI

10.1001/archophthalmol.2009.234

Scopus ID

2-s2.0-70349243148 (requires institutional sign-in at Scopus site)   444 Citations

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.

Author List

Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH, SCORE Study Research Group

Author

Thomas B. Connor MD Professor in the Ophthalmology and Visual Sciences department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Aged
Aged, 80 and over
Female
Fluorescein Angiography
Follow-Up Studies
Glucocorticoids
Humans
Injections
Macular Edema
Male
Middle Aged
Observation
Prospective Studies
Retinal Vein Occlusion
Retreatment
Tomography, Optical Coherence
Treatment Outcome
Triamcinolone Acetonide
Vision Disorders
Visual Acuity
Vitreous Body