Biopharmaceutical firmThromboGenics has started enrolling patients in its Phase II Circle trial, which will evaluate ocriplasmin’s ability to induce total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).
Patients who progress to PDR are at high risk of severe vision loss, and it is the major cause of blindness in patients with diabetes.
The Phase II trial will evaluate up to three intravitreal injections of either 0.125mg or 0.0625mg of ocriplasmin in subjects with moderate to severe NPDR.
Foreseight Studies principal investigator for the Circle Study David Scales said: "There is a clear medical need for a treatment option that is able to prevent patients with NPDR progressing to PDR, a disease state that could result in them losing their sight.
"Achieving this, by using up to three doses of ocriplasmin to generate a total PVD pharmacologically, would be a major advance in the overall treatment of diabetic retinopathy."
A total of 230 people will be enroled in this trial at sites across the US, Canada and EMEA. About 92 will be enroled in each ocriplasmin arm (0.125mg or 0.0625mg) and 46 in the sham arm over the next 12 months.
The trial’s primary endpoint is the percentage of patients with total PVD after three months, confirmed by both B-scan ultrasound and SD-OCT.
Its secondary endpoints are designed to provide further insight into ocriplasmin’s potential in reducing disease progression.
For each patient, the Circle trial will have a duration of about 24 months from the first injection.
The first results are expected to be available in the second half of 2017.