The Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization
Status:
Recruiting
Trial end date:
2022-08-09
Target enrollment:
Participant gender:
Summary
KDR2-2, as a tyrosine kinase inhibitor, has a strong inhibitory effect on VEGFR2 and a
moderate inhibitory effect on PDGFR-β. It can be used for the treatment of corneal
neovascularization. The main purpose of this study is to explore the efficacy and safety of
KDR2-2 suspension eye drops in the treatment of corneal neovascularization. This study is a
single-center, prospective, randomized controlled clinical study. A total of 60 patients with
corneal neovascularization were enrolled in this study, and they were randomly divided into 4
groups, including the control group, the KDR2-2 low-concentration (4mg/ml) group, the
medium-concentration (10mg/ml) group, and the high-concentration (20mg/ml) group, with 15
subjects in each group. The control group applied 0.1% fluorometholone eye drops, and the
test groups applied KDR2-2 suspension eye drops with 0.1% fluorometholone eye drops. Patients
applied KDR2-2 eye drops four times daily for 6 weeks and were followed up to 10 weeks. The
follow-up time points were baseline, 1 week, 2 weeks, 4 weeks, 6 weeks after medication, and
4 weeks after drug withdrawal. Relevant ophthalmological examinations (including visual
acuity, intraocular pressure, slit lamp microscopy, central corneal thickness measurement,
corneal fluorescein staining assessment, corneal sensitivity measurement, corneal confocal
microscope examination, and anterior segment and fundus photography) are performed at each
time. And the ocular tolerability score and adverse events of each patient were recorded. By
comparative analysis, the efficacy and safety of KDR2-2 eye drops in the treatment of corneal
neovascularization were evaluated.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University