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First patient enrolled in phase 2 ocriplasmin study to treat nonproliferative diabetic retinopathy
The first patient has been enrolled in the phase 2 CIRCLE study evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment in patients with nonproliferative diabetic retinopathy, ThromboGenics announced in a press release.
The randomized, double-masked, sham-controlled, multicenter study will include 230 patients with moderately severe to very severe nonproliferative diabetic retinopathy who will receive up to three intravitreal injections of 0.125 mg or 0.0625 mg of Jetrea (ocriplasmin). The duration of the study will be about 24 months for each patient from the first injection.
The primary endpoint of the study is the percentage of patients with total posterior vitreous detachment by month 3, which will be confirmed by B-scan ultrasound and spectral-domain-OCT, the release said.
The company expects to announce first study results in the second half of 2017.