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Kun Liu, Xun Xu, Delun Luo, Xiao Ke; Primary Results Of Recombinant Vascular Endothelial Growth Factor Receptor-antibody Fusion Protein For Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2012;53(14):402.
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To evaluate the efficacy and safety of multiple intravitreal injection of recombinant vascular endothelial growth factor receptor-antibody fusion protein (KH902) for diabetic macular edema (DME).
twenty patients (Group A: 10, Group B: 10), including 9 males and 11 females, with mean age of 62.9 years had been enrolled. 16 patients had completed 3 months of core treatment (8 patients in A and B group each). Comparison of improvement in BCVA, CRT and CRV between baseline and after-core treatment showed increment of 7.85 letters in BCVA (58.00+12.39 vs 65.85+10.96), decrease of 94.23mm in CRT (436.46+94.23mm vs 345.29+49.92mm) and decrease of 0.07 mm3 in CRV (0.34+0.08mm3 vs 0.27+0.04mm3). Further analysis indicated that group A gained increment of 5.83 letters in BCVA (57.00+5.06 vs 62.83+6.05), decrease of 95.33mm and 0.08 mm3 in CRT (424.67+106.28mm vs 329.33 +47.81mm) and CRV (0.34+0.08mm3 vs 0.26+0.04mm3), respectively, and that, for B group, increment of 9.57letters in BCVA (58.86+16.85vs 68.43+13.89), decrease of 86.43mm and 0.07mm3 in CRT (446.57+89.92mm vs 360.14+50.67mm) and CRV (0.35+0.07mm3 vs 0.28+0.04mm3), respectively, were detected. 8 patients had completed one year follow-up. The changes between baseline and 12 month were as follows: increment of 6.13 letters in BCVA (55.63+13.82 vs 61.75+14.52), decrease of 128.50mm in CRT (450.25+88.96mm vs 321.75+40.08mm) and decrease of 0.10 mm3 in CRV (0.36+0.07mm3 vs 0.25+0.03mm3).There were some adverse events such as conjunctival hemorrhage due to intravitreal injection. No serious adverse events related to Kh902 so far.
Multiple intravitreal injection of human recombinant vascular endothelial growth factor receptor-antibody fusion protein (KH902) could efficiently relieve the macular edema of DME patients and improve visual acuity. The preliminary clinical results provided basic data for further multi-center clinical trial in the future.
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