INvestigation of JEtrea® in patients with Confirmed Vitreoma Traction
Research type
Research Study
Full title
INJECT: INvestigation of JETREA® in Patients with Confirmed Vitreomacular Traction
IRAS ID
138391
Contact name
David Steel
Contact email
Sponsor organisation
Alcon Research Ltd
Research summary
Ocriplasmin has recently been approved by the European Medicines Agency (EMA) for treatment of vitreomacular traction (VMT) in adults under the trade name JETREA®.
The long term safety and clinical effectiveness in the real-world setting have not been widely documented in large populations across different countries, and limited data exist that describe health-related quality of life (HRQoL) outcomes in patients treated with ocriplasmin. Therefore, this 12-month, non-randomised, multi-centre study will be conducted, in selected countries worldwide where JETREA® (ocriplasmin) is marketed, to further observe the safety, clinical effectiveness, and HRQoL of this treatment in each country’s approved indicated population.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
13/LO/1737
Date of REC Opinion
26 Nov 2013
REC opinion
Further Information Favourable Opinion