December 2002
Volume 43, Issue 13
ARVO Annual Meeting Abstract  |   December 2002
Adjunctive Anti-TGFß2 Human Monoclonal Antibody as a Novel Agent to Prevent Scarring Following Phacotrabeculectomy
Author Affiliations & Notes
  • DC Broadway
    Norfolk & Norwich University Hospital Norfolk United Kingdom
  • CS Migdal
    Western Eye Hospital London United Kingdom
  • J Salmon
    Oxford Eye Hospital Oxford United Kingdom
  • WA Franks
    Moorfields Eye Hospital London United Kingdom
  • K Barton
    Moorfields Eye Hospital London United Kingdom
  • PT Khaw
    Moorfields Eye Hospital/Institute of Ophthalmology London United Kingdom
  • Footnotes
    Commercial Relationships    D.C. Broadway, Cambridge Antibody Technology F; C.S. Migdal, Cambridge Antibody Technology F; J. Salmon, Cambridge Antibody Technology F; W.A. Franks, Cambridge Antibody Technology F; K. Barton, Cambridge Antibody Technology F; P.T. Khaw, Cambridge Antibody Technology F.
Investigative Ophthalmology & Visual Science December 2002, Vol.43, 3331. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract: : 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.

Keywords: 631 wound healing • 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 423 growth factors/growth factor receptors 

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