TG-MV-005 (MIVI 5) AMD-25JUN2009

• Research type

  Research Study

• Full title

  A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Microplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects with Exudative Age-Related Macular Degeneration (AMD)

• IRAS ID

  17050

• Sponsor organisation

  ThromboGenics NV

• Eudract number

  2008-004844-35

• ISRCTN Number

  NA

• Clinicaltrials.gov Identifier

  NCT00913744

• Research summary

  Microplasmin is an experimental drug that is being testing to evaluate if its injection will induce loosening of the connection between the vitreous (the jelly-like substance in the center of the eye) and the retina. Recent findings support that an attached vitreous and vitreomacular adhesion are both associated with wet AMD (also known as exudative AMD). The potential mechanisms for vitreous attachment leading to worse (wet) AMD include: vitreous traction on the retina leading to chronic inflammation, as well as persistent vitreous attachment to the retina leading to accumulation of toxic chemicals to the retina. Such hypotheses require further testing to confirm. The trial will investigate a single dose of microplasmin: 125 æg. It is planned to enrol 100 patients into the study over approximately a 15 month period, at different centres in Europe. The duration of the participation of the patients is approximately 12 months. Patients will be randomized via a computer system to microplasmin or sham injection in a 3:1 ratio. Neither the patients or the study doctors will know which patients receive microplasmin or sham injection. Potential participants will be required to attend the study doctor??s office for up to 8 visits. A full eye examination will be performed along with additional tests. A patient Information Sheet detailing the purpose of the research as well as details on the proposed exams per visit will be provided to patients prior to participation and the study will be explained by the study doctor.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/13

• Date of REC Opinion

  23 Jul 2009

• REC opinion

  Further Information Favourable Opinion