A Multicentre, Double–Masked, Randomised, Placebo–Control Study to Evaluate the Efficacy, Safety, and Tolerability of Subconjunctival Injections of 100 µG CAT–152 Human Anti–Tgfß2 Monoclonal Antibody as an Agent to Modulate Wound Healing Following First Time Trabeculectomy (Study 0102)

Abstract

Abstract: : Purpose: Adjunctive use of Trabio (CAT–152; lerdelimumab) has shown positive effects in phase II studies in patients undergoing first time trabeculectomy (Study 9802; 24 patients) and first time phacotrabeculectomy (Study 9903; 56 patients). This phase III study was to confirm the efficacy of Trabio in male and female patients with primary open or chronic closed angle glaucoma who were undergoing first time trabeculectomy Methods: 343 patients undergoing first time trabeculectomy were randomised in a double–blind fashion to receive Trabio or placebo. 167 patients received 4 x 100µg dose of Trabio and 171 patients received phosphate buffered saline as placebo: 5 patients discontinued prior to treatment. Trabio or placebo was administered by 100µl subconjunctival injection given in the operating room pre– and post– surgery, and on the 1^st and 7^th day post–surgery Results:330 Patients (96%) completed the 1 year study. The primary analyses were based upon the 274 patients with POAG (96%) and CCAG (4%) and the primary endpoint was a mean IOP in the range 6–16mmHg off–medication at months 6 and 12 post–surgery. 60.0% of Trabio patients versus 68.0% of placebo patients achieved the primary endpoint (p=0.23). There was no evidence of a difference in the use of 5–FU post–surgery (20% Trabio: 17 % placebo) nor in the number of patients requiring either repeat surgery or anti–glaucoma medications (84% Trabio: 87% placebo). Safety assessments showed Trabio to be well tolerated. Conclusions: These results are in contrast to those seen in studies 9802 and 9903. Trabio treated patients showed a success rate in the two previous studies (9802 and 9903) which were consistent with this study of 56.3% and 56.1% respectively versus 60% in this study. Placebo success rates were markedly lower in the previous studies at 37.5% and 35% versus 68% in this study. The results of a second double–masked placebo–controlled phase III study 0201 are awaited.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled • growth factors/growth factor receptors • wound healing