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M. Zhang, M. Yan, J. Zhang, W. Zhu, D. Luo, D. Yu; Safety, Tolerability, and Bioactivity Study of Intravitreal KH902 in Patients With Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5004.
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To determine the safety, tolerability, and bioactivity of intravitreal injection of KH902 in patients with neovascular age-related macular degeneration (AMD). KH902 is a fully human, fusion protein of key domains from VEGF receptor, including the Ig-like domain 4 of VEGFR2, with human IgG Fc.
Patients over 50 years of age with choroidal neovascularization (CNV) due to neovascular AMD with lesion size ≤12 disc areas and best-corrected ETDRS protocol visual acuity (VA) of ≤20/100 were administered a single intravitreal injection of KH902 at 1 of 6 escalating doses (0.05, 0.15, 0.5, 1.0, 2.0 or 3.0 mg per eye) at day 0 with escalation to the next dose level occurring only after the safety and tolerability was established through post-injection day 14 for the previous dose level. Follow-up examinations were performed on postinjection days 1, 3, 7, 14 and 42.
Twenty-five patients were enrolled across 5 dose levels (0.05 mg to 2.0 mg). The results of the first 19 patients are presented. There were no serious or drug-related systemic adverse events; ocular adverse events were mild to moderate in severity. The most common ocular adverse events were transient IOP elevation after KH902 injections and injections-site subconjunctival hemorrhage, There were no reports of significant ocular inflammation or endophathalmitis. The mean VA, foveal thickness (FT), and total macular volume (TMV) were 17.58±16.90 letters,377.58±128.05 microns, and 8.23±1.83 cubic microns, respectively. At Day 42 post-injection, the mean change in VA was +20 letters and no subject lost ≥ 1 letter, and VA improved ≥ 15 letters from baseline in 12 out of 19 subjects. Anatomically, the mean change in foveal thickness was -104 microns and total macular volume was -1.05 cubic microns. The mean decrease in CNV area was 33.3%.
Intravitreal injection of up to 1.0 mg of KH902 has been well-tolerated. Although the number of patients in each cohort is small, KH902 appears to produce rapid clinical effects on VA, supported by improvements in anatomical features, in patients with neovascular AMD.
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