[HTML][HTML] A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema …

MS Ip, IU Scott, PC VanVeldhuisen… - Archives of …, 2009 - ncbi.nlm.nih.gov
MS Ip, IU Scott, PC VanVeldhuisen, NL Oden, BA Blodi, M Fisher, LJ Singerman…
Archives of ophthalmology, 2009ncbi.nlm.nih.gov
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 …
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:
ncbi.nlm.nih.gov