Three Year Follow-Up of an Early Phase Clinical Trial of CAT-152 Anti-TGFß2 Human Monoclonal Antibody as an Adjunct to First Time Trabeculectomy

Abstract

Abstract: : Purpose: In an early phase clinical trial, CAT-152, a human monoclonal antibody that neutralises TGFß2, demonstrated a clinically significant improvement in outcome compared to placebo at 1 year following its use as an adjunct to first time trabeculectomy. Follow-up was extended to investigate whether these observations were maintained over a longer period of time Methods: Twenty-four patients undergoing first time trabeculectomy were randomised to treatment with either CAT-152 (100µg)(n=16) or placebo (phosphate buffered saline)(n=8) given by subconjunctival injection immediately pre- and post-surgery, and at 1 day and 1 week post-surgery. Twenty-one patients completed 3 year follow-up with assessments being conducted at approximately six month intervals. Results: A total of 11 patients were defined to be treatment failures by virtue of receiving injection(s) of 5-FU or re-starting topical IOP lowering medications. Six of eight patients in the placebo group (75%) were treatment failures as compared to 5/16 (31.3%) of patients who had been treated with CAT-152 (p=0.082). Survival analysis of the time to treatment failure showed CAT-152 to be superior to placebo at the 10% level (p=0.072). Mean IOP was consistently lower in the CAT-152 treated patients, with a mean IOP at 36 months of 13.2 mmHg. Bleb appearance in both treatment groups was most frequently reported as diffuse, with normal vascularity. Adverse events were infrequent with no longer term adverse consequences of CAT-152 being observed. Conclusions: The positive results observed at one year have been consistently maintained throughout the 3 year post-surgery follow-up. These results support the utility of CAT-152 when used as an adjunct to first time trabeculectomy. Two large international confirmatory studies have now commenced.

Keywords: clinical (human) or epidemiologic studies: tre • growth factors/growth factor receptors • wound healing