Belgium-based integrated biopharmaceutical firm ThromboGenics will soon start a US Phase IV trial with Jetrea (ocriplasmin) for the treatment of symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT).
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.
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Around 1,500 patients with VMA/ VMT across 120 retina centres in the US will be enrolled in the Ocriplasmin Research to Better Inform Treatment (ORBIT) trial.
The prospective, observational 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.
According to the company, 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.
The trial will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms across time.
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By GlobalDataThe data will further characterise the efficacy and safety profile of the product and provide data complementary to those from the Phase III clinical programme and its first year on the market.
The ORBIT trial is expected to start enrolling patients later this month and is scheduled to be completed in mid-2016.
According to the company, patients will be followed for up to 12 months following treatment with Jetrea.
ThromboGenics CEO Patrik De Haes said: "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."
In the US and Canada, Jetrea is indicated for the treatment of VMA and in Europe for VMT, including when associated with macular hole of diameter =400µ.
Jetrea has been evaluated in two multi-centre, randomised, double-masked Phase III trials carried out in the US and Europe which included 652 patients with VMA.
The company said that both studies met the primary endpoint of resolution of VMA at day 28.
Image: Schematic diagram of the human eye. Photo: courtesy of Rhcastilhos.
