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Lawrence J Singerman, Andreas Weichselberger, Peter Sallstig; OSPREY trial: randomized, active-controlled, phase II study to evaluate safety and efficacy of RTH258, a humanized single-chain anti-VEGF antibody fragment, in patients with neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4801.
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RTH258 is a humanized single-chain antibody fragment that inhibits vascular endothelial growth factor (VEGF), binding with high affinity to all VEGF-A isoforms. RTH258 weighs 26kDa and is significantly smaller than currently available anti-VEGF treatment options. This smaller size may facilitate increased penetration of ocular tissues and reduced systemic exposure. It also allows for delivery of a higher molar dose within a 50µl volume. The OSPREY trial (NCT01796964) was designed to evaluate the safety and efficacy of repeat doses of RTH258 versus aflibercept in patients with neovascular age-related macular degeneration (nAMD).
The OSPREY trial was a randomized, double-masked, active-controlled study of 56 weeks’ duration, designed to test the hypothesis of non-inferiority of RTH258 to aflibercept at weeks 12 and 16. Subjects with untreated active choroidal neovascularization due to AMD were randomized 1:1 to RTH258 or aflibercept.
The Full Analysis Set included 89 patients. Mean age was 78.0 years (range 55.0-96.0 years); 59.6% of subjects were female; 78.7% of subjects had unilateral AMD; mean best-corrected visual acuity was 54.8 ETDRS letters; mean central subfield thickness was 492.9 μm; 33.7% of subjects had intraocular hemorrhage; 84.3% of subjects had hyperreflective material; 89.9% of subjects had subretinal fluid; and 85.4% of patients had intraretinal fluid cystoid edema. Demographic and baseline ocular characteristics are presented in Table 1. Non-inferiority was met, and RTH258 was well tolerated.
The OSPREY trial results support the further development of RTH258. The visual and anatomical outcomes, combined with the data on durability, highlight the potential role of RTH258 in the management of nAMD.
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