Longer Term Follow–up of Adjunctive Anti–TGFß2 Human Monoclonal Antibody as an Agent to Prevent Scarring Following Phacotrabeculectomy.

Abstract

Abstract: : Purpose: Adjunctive use of Trabio^TM (CAT–152; lerdelimumab), a human monoclonal antibody that neutralises TGFß₂, has shown positive effects in a phase II study in patients undergoing first time phacotrabeculectomy. Follow–up of this one year study has been extended to explore the longer term effects of treatment. Methods: 56 patients undergoing first–time phacotrabeculectomy were randomised in a double–blind fashion to receive Trabio or placebo. 36 patients received 4 x 100µg dose of Trabio and 20 patients received phosphate buffered saline as placebo. 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: 89% (32/36) Trabio patients and 75% (15/20) placebo patients completed the second of the 3 year follow–up. Mean IOP without medication, using last observation carried forward for those patients returning to topical medication, was 15.6 mmHg in the Trabio group and 18.6 mmHg in the placebo group. 17% (6/36) of the Trabio group versus 25% (5/20) of the placebo group were deemed failures by virtue of needing to recommence pressure lowering medications. There were no apparent differences in the nature or frequency of adverse events reported between the two groups. Events coded to "Eye Disorders" were the most common, comprising 84% of all events; and of these the most common were in the "Ocular Infections, Irritations and Inflammations" category with 14% Trabio patients and 25% of the placebo patients reporting one or more events. Conclusions: Two year follow–up continues to demonstrate positive trends in favour of adjunctive use of Trabio at the time of phacotrabeculectomy with fewer patients requiring pressure lowering medications post–surgery and lower overall IOP.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • drug toxicity/drug effects • intraocular pressure