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 SCORE Study Report 5
Year of Publication
Ip, M; Scott, I; Van Veldhuisen, P; Oden, N; Blodi, B; Fisher, M; Singerman, L; Tolentino, M; Chan, C; Gonzalez, V; SCORE Study Research Group
Adult; Aged; Female; Fluorescein Angiography; Follow-Up Studies; Glucocorticoids; Injections; macular edema; Male; Middle Aged; Observation; retinal vein occlusion; Retreatment; Tomography-Optical Coherence; Treatment Outcome; Triamcinolone Acetonide
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.