ThromboGenics Completes Patient Enrollment in Microplasmin Trial
September 27, 2009
ThromboGenics NV has announced that it has completed the enrollment of the US Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease. The trial TG-MV-006 has completed enrollment with a total of 326 patients. The second Phase III study, TG-MV-007, which is recruiting patients in the US and Europe is due to complete enrollment in the first half of 2010.
Microplasmin’s Phase III program is referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program. Both of the MIVI-TRUST trials are multi-center, randomized, placebo controlled, double-masked trials which are evaluating 125microg of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion.
The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion after one month. This anatomical endpoint is being measured and recorded using OCT which provides images that can clearly show the separation of the vitreous from the retina. OCT is a very sensitive and specific method for detecting the resolution of focal vitreomacular adhesion. In addition to the primary endpoint, the Phase III trials will evaluate additional measures of efficacy as well as safety, assessed at various time periods over the six month study period.
It is expected that the results from the TG-MV-006 study will be presented by mid 2010.
Read the release.
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