iCo Therapeutics Inc. ("iCo" or "the Company") (TSX-V: ICO) announced today that it has completed enrollment of its Phase 2 iDEAL study evaluating the efficacy and safety after repeated injections of iCo-007 in patients with Diabetic Macular Edema (DME). The study has shown a good safety profile with no drug-related serious adverse events to date.
"The last patient was enrolled and treated on June 17," said Andrew Rae, President & CEO of iCo. "Our principal investigators were interested in extending the timeline in the interest of enrolling as many patients as possible. We look forward to announcing data from the study's primary endpoint early in 2014."
iDEAL Trial Design
The iDEAL trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME—the leading cause of functional visual loss among working Americans, in which leakage of fluid from blood vessels in the eye causes the retina to swell, leading to blurred vision and blindness. The Phase 2 clinical trial is a multi-center study chaired by Quan Dong Nguyen, MD, MSc, Professor and Chair of Ophthalmology and Director of the Stanley M. Truhlsen Eye Institute at University of Nebraska Medical Center ("UNMC") (previously Associate Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine). Recruitment took place at 27 clinical sites across the United States. In addition, the Retinal Imaging Research and Reading Center (RIRRC) based at the UNMC serves as the Reading Center for the iDEAL Study.
The study follows patients for a 12 month period. During the trial, patients were randomized into one of the following four groups:
Mono-therapy using repeated intravitreal dosing of iCo-007 at 350 µg
Mono-therapy using repeated intravitreal dosing of iCo-007 at 700 µg
Combination therapy using repeated intravitreal dosing of iCo-007 at 350 µg with laser photocoagulation
Combination therapy using repeated intravitreal dosing of iCo-007 at 350µg with ranibizumab (Lucentis®) at 0.5 mg
To be eligible for the trial, participants must have type 1 or type 2 diabetes, baseline best corrected visual acuity between 20/32 and 20/320 and DME with central retinal thickness equal to or greater than 250 microns measured byoptical coherence tomography (OCT). .