Date: 2014-04-29
Type of
information: update on patient enrollment
phase: 4
Announcement: update on patient enrollment
Company: Thrombogenics (Belgium)
Product: Jetrea® (ocriplasmin)
Action
mechanism:
- protein. Ocriplasmin is a truncated form of the human serine protease plasmin that retains its enzymatic properties. This small molecule has been designed specifically for use in the eye. It is believed to primarily target the fibronectin, laminin, and type IV collagen fibers that adhere the vitreous to the retina.By dissolving these proteins, ocriplasmin releases the traction, and helps to complete the detachment of the vitreous from the macula.It works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present which may decrease the symptoms caused by VMT. Ocriplasmin is administered through a one-time, single intravitreal injection.
Disease:
Therapeutic
area: Ophtalmological diseases
Country: USA
Trial
details:
- ORBIT (Ocriplasmin Research to Better Inform Treatment) is an observational study designed to generate further data on the real-world use of JETREA® in the US. ORBIT will recruit 1,500 patients with symptomatic vitreomacular adhesion (VMA) 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 15 months on the market. Patients will be followed for up to 12 months following treatment with JETREA®.
Latest
news:
- • On April 29, 2014, ThromboGenics announced that the 50th retina center has been activated to evaluate patients in the US ORBIT Phase IV study with JETREA®. The ORBIT study is due to complete in mid-2016. Data will be presented on a regular basis. First data may be expected as early as by the end of 2014.
- • On March 4, 2014, ThromboGenics 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.
Is
general: Yes
