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First patient enrolled in Zimura trial for Stargardt disease

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The first patient has been enrolled in Ophthotech’s phase 2b trial of Zimura for the treatment of autosomal recessive Stargardt disease, the company announced in a press release.

The randomized, double-masked, sham-controlled clinical trial will assess the efficacy and safety of Zimura (avacincaptad pegol), a complement C5 inhibitor, in 120 patients at more than 30 sites. It will have an anatomic endpoint, the mean rate change in the area of ellipsoid zone defect as measured by en face spectral domain OCT, as the primary endpoint, the release said.

“Recent scientific literature emphasizes the role of complement in Stargardt disease, supporting our strategy for the development of Zimura in this devastating orphan retinal condition,” Kourous A. Rezaei, MD, senior vice president and chief medical officer of Ophthotech, said in the release.

Details of the trial will be presented at the Association for Research in Vision and Ophthalmology meeting in Honolulu, and initial topline data are expected to be available in 2020.

The company also announced it began an open-label phase 2a trial of Zimura in combination with anti-VEGF therapy for idiopathic polypoidal choroidal vasculopathy.