Primary Results Of Recombinant Vascular Endothelial Growth Factor Receptor-antibody Fusion Protein For Diabetic Macular Edema

Abstract

Purpose: : 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).

Results: : 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.

Conclusions: : 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.

Clinical Trial: : http://www.clinicaltrials.gov NCT01324869

Keywords: diabetic retinopathy • vascular endothelial growth factor