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.
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.


METHODS
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.
Ip
Michael S
MS
EMMES Corporation, Rockville, MD 20850, USA.
Scott
Ingrid U
IU
VanVeldhuisen
Paul C
PC
Oden
Neal L
NL
Blodi
Barbara A
BA
Fisher
Marian
M
Singerman
Lawrence J
LJ
Tolentino
Michael
M
Chan
Clement K
CK
Gonzalez
Victor H
VH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007267:Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D019370:Observation; D011446:Prospective Studies; D012170:Retinal Vein Occlusion / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D014786:Vision Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D014792:Visual Acuity / Q000187:drug effects; D014822:Vitreous Body
D005938:Glucocorticoids; D014222:Triamcinolone Acetonide