Original articleA Phase III Study of Subconjunctival Human Anti–Transforming Growth Factor β2 Monoclonal Antibody (CAT-152) to Prevent Scarring after First-Time Trabeculectomy
Section snippets
Study Design
This multicenter, double-masked, randomized, placebo-controlled trial examined the use of a human monoclonal antibody to TGF-β2 (CAT-152) as an adjunct to first-time trabeculectomy. Each patient was treated in 1 eye. Patients were enrolled at 36 sites in 6 countries. The study conformed with the principles of the Declaration of Helsinki, with the good clinical practice protocols of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for
Study Population
A total of 354 patients consented to enter the study; 343 were randomized to receive either placebo or CAT-152; 96% (n = 330) of the randomized patients completed the trial (Fig 1). The ITT analyses were conducted using the data from 2 sets of patients: (1) those diagnosed with POAG or CACG (POAG/CACG group; n = 274); and (2) patients diagnosed with POAG, CACG, PEXG, or PG (+PEXG/PG group; n = 338). Analysis of the safety of CAT-152 was carried out on all patients treated (safety group; n =
Discussion
In this study, CAT-152, an antibody to TGF-β2, was administered as an adjunctive treatment to delay or prevent scarring at the bleb site to patients receiving first-time trabeculectomy for intractable glaucoma. On the primary end point of treatment success (IOP lowering to the target range in the absence of medication or repeat surgery) and the secondary end points of success of surgery, time to surgical failure, IOP, and bleb site anatomic features, no statistically significant difference
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Cited by (0)
Manuscript no. 2006-1173.
Supported by Cambridge Antibody Technology, Cambridge, United Kingdom, and in part by the Biomedical Research Centre, National Institute for Health, Department of Health, London, United Kingdom.
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See Appendix (available at http://aaojournal.org) for Study Group membership.