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D. S. Boyer, Ophthotech Anti-PDGF in AMD Study Group; Combined Inhibition of Platelet Derived (PDGF) and Vascular Endothelial (VEGF) Growth Factors for the Treatment of Neovascular Age-Related Macular Degeneration (NV-AMD) - Results of a Phase 1 Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1260.
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To assess safety of E10030, an intravitreal anti-PDGF aptamer targeting pericytes, in combination with ranibizumab in subjects with NV-AMD.
Dose-escalating, uncontrolled, single- and multiple-dose, multicenter phase 1 study. Included were subjects with predominantly or minimally classic subfoveal NV-AMD ≤ 5 disc areas in total lesion size. Subjects were enrolled in a dose escalation scheme to a single injection of 0.03 mg/eye and 3 monthly injections of ranibizumab 0.5 mg/eye (n=3), or to three monthly injections of one of 4 different doses of E10030 (0.03, 0.3, 1.5, 3.0 mg/eye) and ranibizumab (0.5mg/eye) (n=3-8/dose). Assessments included vital signs and clinical lab tests, complete ocular examination with intraocular pressure, standardized ETDRS visual acuity, color fundus photos and fluorescein angiography, and optical coherence tomography.
No evidence of drug related adverse events were detected. All of the ocular adverse events were associated with the intravitreal injection. In the combined analysis of all subjects to date, 7/22 (32%), 9/20 (45%) and 9/15 (60%) subjects gained ≥ 15 letters at weeks 4, 8, and 12 respectively. The mean change in visual acuity was +11.1, +13.4 and + 15.7 ETDRS letters at weeks 4 (n=22), 8 (n=20), and 12 (n=15). The mean center point retinal thickness was 395µm at baseline, 251µm at week 4, 231µm at week 8, and 229µm at week 12. 85% of lesions exhibited neovascular regression to date as assessed by fluorescein angiography.
E10030 combined with ranibizumab in patients with subfoveal NV-AMD was well tolerated in this Phase 1 study. Although limited by the small sample size, short follow-up, and lack of a control group, results suggest potential bioactivity associated with regression of the neovascular membrane.
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