CAT-152 Study in Trabeculectomy Trial

¹Yun S. H., ²Jünemann A., ³Karasheva G., ²Küchle M., ¹Schwenn O., ⁴Spiegel D., ¹Vogel A., ³Wimmer I., ³Grehn F.,
¹Johannes-Gutenberg-Universität Mainz, Universitäts-Augenklinik (Mainz)
²Friedrich-Alexander-Universität, Augenklinik (Erlangen)
³Bayerische Julius-Maximilians-Universität Würzburg, Universitäts-Augenklinik (Würzburg)
⁴Universität Regensburg, Klinik und Poliklinik für Augenheilkunde (Regensburg)

Background: Scarring is a main reason for the surgical failure. Antimetabolites are used for the inhibition of the scarring, but standardized indications and dosages are missing. Additionally serious complications are possible particularly in long-term process.
Objective: CAT-152 (manufacturer: Cambridge Antibody Technology) is a human monoclonal antibody that neutralises TGFß₂ that is being developed as an agent to modulate wound healing. In a multicenter, double-masked, randomised, placebo-control study the efficacy, safety, and tolerability of the new substance are evaluated in six european countries.
Material and methods: Patients with primary open angle glaucoma, showing visual field defects or optic disc changes, who require first time trabeculectomy, are recruited. The study medication or placebo is injected subconjunctivally in a standardized manner. The intraocular pressure, visual field and optic disc are examined regularly. The bleb in particular is judged by different aspects (criteria after Professor Grehn). Additionally different laboratory tests are done to ensure the safety. The follow-up is 12 months. Primary outcome measures are IOP as well as frequency and time of postoperative interventions.
Results: The study began early 2002 in Germany. Currently approximately 50 patients are recruited in Europe.

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