The one-year results of the SCORE study were published in September. The studies (two really, one comparing standard of care vs. intravitreal triamcinolone (IVTA) injections in central retinal vein occlusion (CRVO), and the other in branch retinal vein occlusion (BRVO). Here I’ll discuss the results in the CRVO study. Standard of care for CRVO with macular edema is observation. No effective treatment has been available, to reduce the macular edema and improve vision. The SCORE study has shown that IVTA at a 1 mg dose is indeed effective at improving vision in CRVO with macular edema. How effective? Those who were in the observation group had a 7% rate of improvement in vision, whereas those in the IVTA group had 26% improvement in vision. Although this is nearly a five-fold increase in the rate of improvement, it bears mentioning that nearly 3/4 of patients who did receive IVTA did not gain the levels of vision defined as the endpoint of the study. The study compared 1 mg and 4 mg doses of preservative free triamcinolone, and found that the success rate was essentially the same (27% and 26% respectively), but that the higher dose had increased risk of cataracts and IOP. 271 patients were enrolled in the study.
Bottom line: A single 1 mg dose of IVTA results in 26% of patients with CRVO and ME gaining 3 or more lines of vision, vs. 7% with observation. The shortcoming of the data is that we only have 1 year results. Time will tell whether the improvement will hold.
Here are links to the NIH/NEI press release, the article on Medscape. The abstract is below.
Arch Ophthalmol. 2009 Sep;127(9):1101-14.
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.
Ip MS, Scott IU, VanVeldhuisen PC, Oden NL, Blodi BA, Fisher M, Singerman LJ, Tolentino M, Chan CK, Gonzalez VH; SCORE Study Research Group.
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.