Clinical Trials

Date: 2016-12-23

Type of information: update on patient enrollment

phase: 2

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: posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR)

Therapeutic area: Ophtalmological diseases

Country: USA

Trial details:

• The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of up to 3 intravitreal injections of either 0.125mg or 0.0625mg of ocriplasmin in subjects with moderately severe to very severe non-proliferative diabetic retinopathy, to induce total posterior vitreous detachment in order to reduce the risk of the patient developing sight-threatening proliferative diabetic retinopathy.(NCT02681809)

Latest news:

• • On December 23, 2016 ,  ThromboGenics announced that the protocol of the Phase II CIRCLE Trial evaluating multiple doses of THR-409 to induce a total posterior vitreous detachment in patients with non-proliferative diabetic retinopathy has been amended. The changes will allow inclusion of patients with less severe non-proliferative diabetic retinopathy (ETDRS level 43A - 47A). This will result in a broader patient pool for the study to recruit from. The amended study is now expected to enroll approximately 115 patients. • On January 13, 2016 ,ThromboGenics announced that the first patient has been enrolled in its Phase II CIRCLE study evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). ThromboGenics hopes to be able to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR) by inducing a total PVD using ocriplasmin. PDR is the major cause of blindness in patients with diabetes. Patients who progress to PDR are at high risk of experiencing severe vision loss or complete blindness. A total of 230 subjects will be recruited into the CIRCLE trial, approximately 92 in each ocriplasmin arm (0.125mg or 0.0625mg) and 46 in the sham arm, over the next 12 months. Patients will be accrued from sites across the US, Canada and EMEA. The primary endpoint of the CIRCLE study is the percentage of patients with total PVD by the month 3 visit, confirmed by both B-scan ultrasound and SD-OCT. The study has a number of exploratory secondary endpoints that are designed to provide further insight into ocriplasmin's potential in reducing the risk of progression of NPDR to PDR. For each patient recruited, the CIRCLE study duration will be approximately 24 months from the first injection. The first results are anticipated to be available in the second half of 2017.
• • On November 12, 2015, ThromboGenics, an integrated biopharmaceutical company focused on developing and commercializing innovative medicines for the treatment of vitreo-retinal disorders, announced that the FDA has accepted its Investigational New Drug (IND) Application for its CIRCLE study, a Phase II, randomized, double-masked, sham-controlled, multi-center study that will evaluate the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment in subjects with non-proliferative diabetic retinopathy.
• CIRCLE will evaluate Jetrea® for the treatment of patients with moderately to very severe NPDR and its potential to reduce their risk of progression to proliferative diabetic retinopathy. The phase II study will be conducted in clinical sites in the United States as well as in several European countries. ThromboGenics remains on track to recruit the first patient in the United States around year-end 2015.
• ThromboGenics and its clinical advisors believe that by using Jetrea® to generate a posterior vitreous detachment, the development of proliferative diabetic retinopathy and its sequelae may be prevented. Posterior vitreous detachment induction eliminates the scaffold for which new blood vessels may bleed into the vitreous. This belief is reinforced by the fact that the complications of PDR are less in patients who have a posterior vitreous detachment.

Is general: Yes