Phase I trial of Novagali's investigational DME injection begins
Cortiject, Novagali Pharma's investigational treatment for Diabetic Macular Oedema (DME), has successfully been injected into the first patient in its Phase I clinical trial.
Cortiject, Novagali Pharma's investigational treatment for Diabetic Macular Oedema (DME), has successfully been injected into the first patient in its Phase I clinical trial. Cortiject is an injectable emulsion containing a corticosteroid; the open-label, dose-escalation trial, evaluating safety and efficacy, will enrol 15 patients.
Patients in the study will be segmented into three arms, each being treated with different doses of a single intravitreal Cortiject injection. The prodrug will remain in the patient's system for nine months, and follow-up will be for 12 months.
Novagali Pharma received the FDA Investigational New Drug Application (IND) for this trial in January 2008.
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