Pilot study focuses on off-label use of bevacizumab

October 1, 2006
Nancy Groves

About one-third of patients displayed improvement in visual acuity at 1, 2, and 3 months after injection.

About one-third of patients displayed improvement in visual acuity at 1, 2, and 3 months after the initial injection, he said.

"These are short-term results from only one center," said Dr. Spaide, a retina specialist with Vitreous Retina Macula Consultants of New York. "However, the results are somewhat favorable in terms of visual acuity outcomes, especially in consideration of the low number of side effects and the low cost of treatment. It certainly makes it interesting to look at a larger trial."

The mean age of the patients was 80.3 years, and the mean visual acuity was 20/184. Baseline ocular coherence tomography (OCT) measurements were obtained for 214 patients, resulting in a mean central foveal thickness ± SD of 340 ± 206 µm. The mean follow-up was 98 days.

Visual acuity improves

One-month follow-up data were available for 244 eyes; mean visual acuity was 20/131 (p <0.001) and 33.5% of patients displayed improvement in visual acuity. Thirteen patients (6.1%) had worse visual acuity.

Central retinal measurements performed with OCT were available for 170 patients. The mean central macular thickness ± SD was 250 ± 190 µm, significantly less than the baseline readings (p <0.001). In addition, 80% of patients had a reduction in their central macular thickness at this time point. Neither the absolute change nor the proportional change was associated with change in visual acuity.

Safety results at 1 month showed that two patients had mild vitritis; one had a history of previous recurrent uveitis. In the other patient, spontaneous resolution occurred by the 2-month follow-up.

Two-month data were available for 222 eyes. At this time, the mean visual acuity was 20/122, an improvement over the mean baseline acuity of 20/184 (p <0.001). Investigators found that 78 patients (31.1%) had better visual acuity, compared with only 17 patients whose visual acuity had worsened. Of two patients with cells in the vitreous at this time, one had spontaneous clearing. The other, who had a history of chronic uveitis, continued to have cells at this site but did not require treatment.

By the 3-month follow-up, when data were available for 141 eyes, mean visual acuity had improved again, to 20/109. Overall, 54 patients (38.3%) had improved visual acuity, and 10 had worse vision.

As at 1 month, there was no statistically significant correlation at either 2 or 3 months between change in macular thickness and change in visual acuity. Analysis also indicated that patients who had been treated with some other form of therapy before this study had the same change in visual acuity as those treated primarily with bevacizumab; this was observed at all time points.

The drug appeared to be safe during the brief study period, Dr. Spaide said. There were no occurrences of endophthalmitis, increased IOP, retinal tears, or retinal detachment, and no patient had an anterior chamber reaction at any time.