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news.ThromboGenics will soon start a prospective, observational Phase IV trial in the US with Jetrea (ocriplasmin) to treat symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT).
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Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play a major role in VMA.
The Ocriplasmin Research to Better Inform Treatment (ORBIT) trial will include about 1,500 patients with VMA/ VMT across 120 retina centres in the US.
Patient enrollment is expected to start later this month in the ORBIT trial, which is scheduled to be completed in mid-2016.
The trial will evaluate clinical outcomes and safety of Jetrea administered in a real-world setting for the treatment of symptomatic VMA/VMT by assessing both anatomical and functional outcomes.
The company said that the trial will look at a number of parameters including resolution of VMA, Full Thickness Macular Hole (FTMH) closure, changes in visual acuity (VA) and occurrence and time to vitrectomy.
Adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time will also be monitored in the trial.
Data from the trial will further characterize the efficacy and safety profile of the product and provide data complementary to those from the Phase III clinical program and its first year on the market.
According to the company, patients will be followed for up to 12 months following treatment with Jetrea.