Ophthotech has completed patient enrolment in its Phase llb clinical trial of Zimura (avacincaptad pegol) to treat patients with geographic atrophy secondary to dry age-related macular degeneration (AMD).
A total of 286 patients have been enrolled for the randomised, double-masked, sham controlled multi-centre clinical trial.
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The trial aims to evaluate the safety and efficacy of various doses of Zimura over a period of 12 months, followed by treatment and monitoring of patients for 18 months.
Ophthotech chief medical officer Kourous Rezaei said: “Recent clinical data together with the pre-clinical scientific evidence implicating complement in various retinal diseases further invigorates our enthusiasm for the therapeutic potential of Zimura.
“We look forward to initial top-line data from this clinical trial, which is expected to be available during the fourth quarter of 2019.”
Zimura is developed to target and inhibit the complement protein C5.
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By GlobalDataThe solution is also being studied in combination with anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) at 0.5mg in treatment-naïve wet AMD patients as part of an open-label Phase lla trial.
The randomised, dose-ranging, open-label, uncontrolled, multi-centre trial has included 64 patients.
The trial is expected to provide initial top-line results by the end of this year.
Based on the results, Ophthotech will decide whether to proceed to a randomised, sham-controlled clinical study of Zimura combination therapy with anti-VEGF in wet AMD.
In addition, Zimura is being investigated in a Phase llb clinical trial in patients with autosomal recessive Stargardt disease (STGD1).
