Microplasmin - Back of the Eye Disease: Phase III clinical program to evaluate non-surgical treatment of patients with vitreomacular adhesion.
- Phase III program continues to progress well, with enrolment
completed for TG-MV 006 and on track for TG-MV 007
In September, ThromboGenics announced the completion of patient recruitment in the US trial (TG-MV-006) of the Phase III program with microplasmin for the non-surgical treatment of vitreomacular adhesion (a back of the eye condition). The trial recruited a total of 326 patients ahead of schedule and we anticipate reporting the results from this study by mid 2010, after a 6 month follow up period.
The second Phase III study with microplasmin, TG-MV-007, which is recruiting 320 patients in Europe and the US, is progressing well and we expect complete enrolment within the first quarter of 2010 and results of this study near the end of 2010.
This Phase III program, referred to as the MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment) program, comprises two clinical trials, taking place in the United States (TG-MV-006 trial) and a second combined European and US study (TG-MV-007 trial). The indication for both of these Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Vitreomacular adhesion is a condition in which the vitreous has an abnormally strong adhesion to the retina at the back of the eye. These adhesions can cause vessel and retinal distortion, which results in deterioration in the patient's vision. Both of these trials use the 125micro g dose of microplasmin.
Microplasmin - Diabetic Retinopathy: Phase II trial to evaluate
microplasmin for the treatment of Diabetic Macular E
|SOURCE ThromboGenics NV|
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