Industry News — Clinical Updates
ThromboGenics Activates 50th Retina Center for Jetrea ORBIT Phase IV Study
ThromboGenics, Inc. (Iselin, NJ) has announced that the 50th retina center has been activated in the US for the Ocriplasmin Research to Better Inform Treatment (ORBIT) Phase IV study. ORBIT is an observational study designed to generate further data on the real-world use of Jetrea (ocriplasmin) in the US.
The prospective, observational study will assess clinical outcomes and safety of Jetrea administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) and vitreomacular traction (VMT) by assessing both anatomical and functional outcomes.
ORBIT will look at a number of parameters:
- Resolution of VMA
- Full-thickness macular hole (FTMH) closure
- Changes in visual acuity (VA)
- Occurrence and time to vitrectomy
The study will also monitor adverse drug reactions and changes from baseline in ocular signs and symptoms across time. These data will further characterize the efficacy and safety profile of Jetrea and provide data complementary to those from the phase III clinical program and its first 15 months on the market.
Orbit will recruit 1500 patients with symptomatic VMA across 120 retina centers in the US, and patients will be followed for up to 12 months following treatment. Patient enrollment is open and underway at all activated sites.
The ORBIT study is due to complete in mid-2016, with early data possibly reported as soon as the end of 2014.
Updated April 29, 2014