Ophthotech announced completion of patient recruitment for its phase 2b clinical trial of Zimura (avacincaptad pegol), the company’s complement factor C5 inhibitor, monotherapy in patients with geographic atrophy secondary to dry age-related macular degeneration (AMD).
Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of AMD. A total of 286 patients have been enrolled into this randomized, double-masked, sham controlled multicenter clinical trial. This clinical trial is designed to assess the safety and efficacy of various Zimura dosing regimens over 12 months. Patients will continue to be treated and monitored until month 18.
“We are grateful to our principal investigators and their dedicated clinical staffs for their interest and support of our Zimura program, enabling on time completion of recruitment for our clinical trial in patients with geographic atrophy secondary to dry AMD,” Kourous A. Rezaei, MD, Chief Medical Officer of Ophthotech, said in a company news release. “Recent clinical data together with the preclinical 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.”
The company also expects initial topline data for its open-label phase 2a clinical trial of Zimura combination therapy with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) 0.5 mg in treatment-naïve patients with wet AMD before the end of this year. A total of 64 patients have been enrolled into this randomized, dose-ranging, open-label, uncontrolled, multicenter trial. This trial is designed to assess the safety of different dosages of Zimura in combination with Lucentis and to detect a potential efficacy signal at month 6. Following the completion of this trial, clinical data will be analyzed to assess whether to proceed to a randomized, sham-controlled clinical trial of Zimura combination therapy with anti-VEGF in wet AMD.
Further, Zimura is being evaluated in a phase 2b clinical trial in patients with autosomal recessive Stargardt disease (STGD1) and clinical trial sites are currently enrolling patients. Patients interested in additional information about this study can call toll-free 1-833-STGD1-OP (1-833-784-3167).
More information on these clinical trials is provided at www.clinicaltrials.gov.