NCT05011916

The Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization

An Exploratory Clinical Study on the Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corneal Neovascularization

Interventions

Type	Name	Description
DRUG	KDR2-2 suspension eye drops	All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.

Timeline

• Start date: 2021-08-10
• Primary completion: 2022-08-09
• Completion: 2022-08-09
• First posted: 2021-08-18
• Last updated: 2021-08-18

Locations

2 sites across 1 country: China