VANCOUVER, British Columbia — iCo Therapeutics announced it will work with JDRF on a phase 2 clinical study of whether iCo-007 can improve visual acuity in patients with type 1 or type 2 diabetes who have diabetic macular edema, according to an iCo news release.
The multicenter iDEAL trial will enroll as many as 208 patients with DME at as many as 30 sites in the United States to study varying combinations and concentrations of iCo-007, an antisense drug targeting c-Raf kinase, the release said.
Patients are now being recruited for the trial and will be followed for 12 months, according to the release. They will be randomized into either a monotherapy arm using intravitreal dosing of two concentrations of iCo-007 or a combination arm using iCo-007 with laser photocoagulation or iCo-007 and Lucentis (ranibizumab, Genentech).
“Using both a monotherapy as well as combination therapy approach should uncover the potential of this novel drug for treatment of a wider DME patient population,” Peter Hnik, MD, MHSc, chief medical officer of iCo, said in the release. “The primary endpoint of the iDEAL trial is a change in visual acuity from baseline to month 8. Secondary endpoints include visual acuity at month 12; retinal thickness as measured by OCT at month 8 and 12; duration of the effect of iCo-007 at month 12; and safety.”
An open-label, dose-escalating phase 1 safety trial of iCo-007 demonstrated no drug-related serious adverse events, signs of ocular inflammation, IOP issues or systemic exposure.