Ophthotech enlists first patient for Phase 2b Clinical Trial of Zimura to treat STGD1
Ophthotech Corporation enrolled first patient in the Phase 2b randomized, double-masked, sham-controlled clinical trial assessing the efficacy and safety of Zimura complement C5 inhibitor in patients with autosomal recessive Stargardt disease (STGD1) which is an innate orphan retinal disease causing vision loss during childhood or adolescence. Over 30 sites have been detected for this Clinical Trial rendering it one of the efficient Clinical Trials for STGD1.
Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech said “We look forward to 2018 with our ongoing clinical programs in dry AMD, wet AMD and IPCV. We continue our search for new opportunities that are in sync with our commitment to develop novel therapeutics for age-related and orphan diseases in the back of the eye.”
The Company bids to enroll approximately 120 patients in this trial and plans to use an anatomic endpoint, the mean rate of change in the area of ellipsoid zone defect as measured by en face spectral domain optical coherence tomography (SD-OCT), as the primary endpoint, which will be assessed at 18 months. Initial top-line data is expected to be available in 2020. Similarly Ophthotech also claimed that it intends to undertake an open-label Phase 2a clinical trial assessing Zimura in combination with anti-vascular endothelial growth factor (VEGF) therapy for idiopathic polypoidal choroidal vasculopathy (IPCV), an age-related retinal disease.