RESUMO
PURPOSE: The human monoclonal antibody that neutralizes the growth factor TGFbeta(2) (CAT-152) safely and effectively inhibits in vitro and in vivo models of conjunctival scarring. This phase I/IIa clinical trial was designed to assess the safety and tolerability of CAT-152 in patients undergoing trabeculectomy. DESIGN: Prospective randomized placebo-controlled clinical trial. PARTICIPANTS AND CONTROLS: Twenty-four patients who were due to undergo primary trabeculectomy at Moorfields or Western Eye Hospitals in London, England, were recruited for this study and randomly assigned to treatment with either CAT-152 (100 microg in 100 microl) (n = 16) or placebo (n = 8). METHODS: The treatment regimen was a series of four 100-microl subconjunctival injections, given immediately before and after surgery, and at 1 day and 1 week postoperatively. Assessment consisted of a full ophthalmic examination with recordings of the logarithm of the minimum angle of resolution visual acuities performed at baseline and at set intervals after surgery. Any adverse events were recorded. MAIN OUTCOME MEASURES: Logarithm of the minimum angle of resolution visual acuity, intraocular pressure, complications, and adverse events. RESULTS: The results of 12 month's follow-up on all patients are documented. There were no statistically significant differences in the incidence of complications between the two groups, and no serious adverse events related to the study drug occurred. Blebs after CAT-152 antibody treatment were diffuse, noncystic, and nonavascular, unlike blebs associated with antimetabolites. The fall in intraocular pressure was greater in the CAT-152 group at 3 and 6 months (P < 0.05) and approached statistical significance at 12 months. There was a trend toward less intervention in those patients treated with CAT-152. The small number of patients included limited the power of the study (34%) to detect a difference between groups. Sixteen patients in each arm of the study would be required to obtain a power of 90% with a 5% significance level. CONCLUSIONS: This is the first clinical study of CAT-152 in patients undergoing glaucoma filtration surgery. CAT-152 seems to be well tolerated, and based on these results further multicenter trials are underway.