Vancouver, British Columbia—iCo Therapeutics Inc. announced it has completed enrollment of its phase II iDEAL Study, which will evaluate the efficacy and safety after repeated injections of iCo-007 in patients with diabetic macular edema (DME).
To date, the study has shown a good safety profile with no drug-related serious adverse events.
“The last patient was enrolled and treated on June 17,” said Andrew Rae, president and chief executive officer of iCo Therapeutics. “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.”
The iDEAL trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME. The phase II clinical trial is a multicenter study, chaired by Quan Dong Nguyen, MD, professor and chairman of ophthalmology and director of the Stanley M. Truhlsen Eye Institute at the University of Nebraska.
Recruitment took place at 27 clinical sites across the United States. The study follows patients for a 12-month period. During the trial, patients were randomly assigned to one of four groups:
- Monotherapy using repeated intravitreal dosing of iCo-007 at 350 µg
- Monotherapy 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 350 µg with ranibizumab at 0.5 mg
For more information about this study, visit www.clinicaltrials.gov.
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