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DC Broadway, CS Migdal, J Salmon, WA Franks, K Barton, PT Khaw; Adjunctive Anti-TGFß2 Human Monoclonal Antibody as a Novel Agent to Prevent Scarring Following Phacotrabeculectomy . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3331.
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Purpose: This second clinical trial of CAT-152, a neutralising anti-TGFß 2 human monoclonal antibody, was designed to assess safety and tolerability when used as an adjunct to prevent scarring following phacotrabeculectomy. Methods: Fifty-six patients undergoing first-time phacotrabeculectomy were recruited and randomised in a masked fashion to treatment with either 100µ g CAT-152 (n=36) or placebo (n=20). Treatment consisted of 4 subconjunctival injections (100µ l) given immediately before and after surgery, and at 1 day and 1 week post-surgery. Patients were assessed at regular intervals post-surgery with a full ophthalmic examination including LogMAR visual acuity. Results: At six months post-surgery, compared with the control patients, those treated with CAT-152 reported less overall adverse events and less ocular adverse events, the most common class of adverse event. No serious CAT-152 related adverse events or injection site reactions occurred. Bleb appearance was typically diffuse and of normal vascularity. There was no difference in visual acuity at 6 months. Mean IOP was lower in the CAT-152 treatment group (14.5mmHg) compared with the control group (16.6mmHg) although there was no significant difference in IOP reduction from baseline (ANCOVA; p=0.574). One patient (5%) in the control group required re-do surgery and a further 2 patients (10%) required topical medication compared with none requiring surgery and 3 patients (8%) requiring topical medication in the CAT-152 treatment group. Overall, a greater proportion of CAT-152 treated patients than controls achieved pressures <22 mmHg (100% versus 80%; p=0.013), although with more early post-operative bleb manipulation (25% versus 10% 5-FU ± Needling). Conclusion: This second clinical study of CAT-152 in phacotrabeculectomy builds upon the previous study in first time trabeculectomy. No safety issues have been observed and CAT-152 appears well tolerated. Patient follow-up continues to assess longer term outcomes and larger studies are being implemented.
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