ThromboGenics NV has announced that it is to shortly initiate a US Phase IV study with JETREA®. The Ocriplasmin Research to Better Inform Treatment (ORBIT) study is designed to generate further data on the real-world use of JETREA®.
The ORBIT study will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) patients across 120 retina centers 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 VMA/VMT by assessing both anatomical and functional outcomes.
The study 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. It will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time. These data 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.
Patients will be followed for up to 12 months following treatment with JETREA®. The ORBIT study is expected to start recruiting patients this month and is due to complete in mid-2016.
Dr Patrik De Haes, CEO of ThromboGenics, comments: “The start of the ORBIT study in the US reflects ThromboGenics’ commitment to gain further knowledge on the real world use of JETREA®. We feel that it is important with such a novel treatment option as JETREA® to conduct a significant post marketing study in order to assess which patients gain the greatest benefit from the first pharmacological option that is designed for the treatment of symptomatic VMA/VMT. The desire for more information on the real-world experience with JETREA® is shared by our partner Novartis/Alcon which is conducting a parallel patient study outside the US.”