一项2b期研究发现,接受新型抗PDGF复合物E10030(Fovista)联合雷珠单抗治疗的湿性AMD患者视力损失显著减少。这项纳入449例患者的研究达到了预先规定的主要有效性终点(即与雷珠单抗单药相比,联合用药平均获得的视力)来自美国菲尼克斯市亚利桑那视网膜顾问机构的Pravin U. Dugel医学博士报告。
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PA009
Targeting Platelet Derived and Vascular Endothelial Growth Factors for Neovascular AMD: Phase 1 Study
Purpose: To assess the safety of E10030, an anti-PDGF PEGylated aptamer combined with ranibizumab for neovascular AMD.
Methods: Predominantly or minimally classic neovascular AMD lesions were treated in a dose-escalation scheme with 1–3 monthly E10030 injections (0.3, 1.5, or 3.0 mg) combined with 1–3 monthly ranibizumab injections.
Results: No drug-related adverse events were detected. Fifty-nine percent of subjects gained ≥ 15 letters at Week 12 (n = 22), mean letter gain was +14.0, mean change in OCT center point was -157 μm, and 85% of patients exhibited neovascular regression.
Conclusion: E10030 combined with ranibizumab was well tolerated, with resultant significant neovascular regression. |