Update: CRVO primary outcomes

February 15, 2010

A 1-mg dose of intravitreal triamcinolone had a safety profile superior to that of a 4-mg dose of intravitreal triamcinolone and produced visual acuity increases similar to the 4-mg groupand better than the standard-of-care group, according to the primary outcomes of a randomized clinical trial.

San Francisco-A 1-mg dose of intravitreal triamcinolone had a safety profile superior to that of a 4-mg dose of intravitreal triamcinolone and produced visual acuity (VA) increases similar to the 4-mg group and better than the standard-of-care group, according to the primary outcomes of a randomized clinical trial.

Study investigators concluded that the lower dose should be considered as a treatment option for patients with macular edema (ME) associated with central retinal vein occlusion (CRVO). Michael S. Ip, MD, highlighted the primary results of the Standard Care Versus Corticosteroid for Retinal Vein Occlusion Study (SCORE-CRVO) for the SCORE Research Study Group during retina subspecialty day at the annual meeting of the American Academy of Ophthalmology.

The SCORE Study, which was sponsored by the National Eye Institute, compared the VA outcomes in patients with ME associated with CRVO who were randomly assigned to one of two doses (1 or 4 mg) of intravitreally administered triamcinolone compared with patients who were randomly assigned to observation.

The mean patient age was 68 years; most patients (91%) were Caucasian. The mean VA letter score was 51, representing about 20/100 Snellen acuity. Patients had ME for a mean of 4 months; the mean centerpoint thickness was 659 µm. At 1 year, in the observation group, patients completed 83% of the visits and in the 1- and 4-mg groups 90%. The percentages of visits completed tapered at 24 and 36 months due to common closeout, Dr. Ip said.

The mean numbers of injections in the 1- and 4-mg groups were similar, 2.2 and 2; 49% of those in the 1-mg group required a third injection compared with 32% in the 4-mg group.

The gain in the VA letter score of 15 or more was the primary outcome; 27% and 26% met that outcome in the 1- and 4-mg groups, respectively, and 7% in the observation group. Compared with the observation group, the increases in letter scores were significant (p < 0.001; odds ratio, 5 for both comparisons) in both triamcinolone groups. The difference between the two treatment groups was not significant (p = 0.97; odds ratio, 1).

"With each 4-month follow-up visit, the proportion of patients with a gain in the VA letter score of 15 letters or more was greater for both triamcinolone groups compared with the observation group," Dr. Ip said.

Conversely, when analyzed by the 4-month follow-up visit, the loss in the VA letter score increased in the observation only group compared with the two triamcinolone groups.

For each 4-month follow-up visit, the mean change from baseline in the VA letter score favored the triamcinolone groups. At month 12, the primary outcome point, the mean change was –12.5 letters in the observation group compared with –1.2 letters in the triamcinolone groups.