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Microplasmin for treatment of Focal Vitreomacular Adhesion - Version 1

  • Research type

    Research Study

  • Full title

    A randomized placebo controlled double masked multicenter trial of Microplasmin intravitreal injection for non-surgical treatment of Focal Vitreomacular Adhesion

  • IRAS ID

    11964

  • Sponsor organisation

    ThromboGenics

  • Eudract number

    2008-004393-40

  • ISRCTN Number

    NA

  • Clinicaltrials.gov Identifier

    NCT00781859

  • Research summary

    Microplasmin is an experimental drug under study to determine if it will loosen the connection between the vitreous (the jelly-like substance in the center of the eye) and the retina (the light sensitive part of the eye responsible for vision). Certain eye diseases that are associated with the vitreous pulling on the retina can result in problems with vision and other complications. An option for treatment for these eye diseases is a type of eye surgery called a vitrectomy (surgery to loosen the vitreous from the retina, often associated with complications). A potential alternative to vitrectomy is the use of Microplasmin, which could potentially loosen the connection between the vitreous and the retina after injection into the eye. Microplasmin injection may offer an alternative to vitrectomy and the associated complications with this procedure may be avoided. Patients in the study will be randomized via a computer system and will receive an intravitreal (into the eye) injection of either Microplasmin or placebo (an identical injection that contains no active Microplasmin) in a 3:1 ratio (3 in 4 patients will receive the active microplasmin injection). Neither the patients nor the study doctors will know which patients receive the active microplasmin or placebo injection. Potential patients for this trial will be identified via routine clinic, review of medical notes and colleague referrals. Potential participants are required to attend the study doctor??s office for up to 7 visits. A full eye examination will be performed along with additional tests which are routine for patients with eye diseases associated with the vitreous pulling on the retina. 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

    08/H1010/114

  • Date of REC Opinion

    3 Feb 2009

  • REC opinion

    Further Information Favourable Opinion