ThromboGenics to initiate post-marketing trial of Jetrea
ThromboGenics plans to initiate a U.S. phase 4 study of Jetrea this month, according to a press release.
The Ocriplasmin Research to Better Inform Treatment (ORBIT) study will generate more data on the real-world use of Jetrea (ocriplasmin).
The prospective, observational study will recruit 1,500 patients with symptomatic vitreomacular adhesion or vitreomacular traction across 120 U.S. retina centers and assess clinical outcomes and safety of Jetrea administered in a real-world setting through anatomical and functional outcomes.
Primary outcome measures will include resolution of VMA, full-thickness macular hole closure, changes in visual acuity, and occurrence and time to vitrectomy, the release said.
Adverse drug reactions and changes in ocular signs and symptoms from baseline will also be evaluated.
Patients will be followed for up to 12 months.
The study is expected to start recruiting patients later this month. Its estimated completion date is mid-2016.
In a separate press release, ThromboGenics announced that its board of directors is exploring strategic options to increase the company’s ability to commercialize Jetrea in the U.S. Morgan Stanley has been retained to help with the strategic review process.