Clinical trial NCT05011916: The Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization
Official title: An Exploratory Clinical Study on the Safety and Efficacy of KDR2-2 Suspension Eye Drops in the Treatment of Corneal Neovascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Corneal Neovascularization
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. voluntarily participate in the trial, sign the informed consent form, and follow up according to the time specified by the trial;
2. 18\~75 years old, without gender limit;
3. Superficial or deep corneal progressive neovascularization induced by trauma, chemical burns, corneal transplantation and inflammation: the growth of corneal new vessels≥ 2 mm from the limbus within 1 week to 2 months.

Exclusion Criteria:

1. Obvious corneal epithelial defects (\>1mm), or a history of persistent corneal epithelial defects in the past 3 months (\>1mm, ≥14 days);
2. Anti-VEGF drugs have been injected locally in the target eye within 3 months, or anti-VEGF drugs have been used systemically within 2 months;
3. Recent eye surgery (except for keratoplasty) within 3 months, or planned eye surgery during the trial period;
4. Systemic use of glucocorticoid drugs, or intraocular or periocular injection of glucocorticoid drugs within 1 month;
5. Contact lenses use within the past 2 weeks (except bandage lenses);
6. Stable corneal neovascularization: \> 6 months;
7. History of coagulation abnormalities (such as end-stage liver disease), or current anticoagulant drugs other than aspirin (such as warfarin, heparin, enoxaparin or similar anticoagulants);
8. Uncontrolled clinical problems (such as tumors, HIV infection, hepatitis C virus infection, active hepatitis B or other serious chronic infections, serious mental, neurological, cardiovascular, urinary, respiratory and other system diseases, etc.); Uncontrolled hypertension: systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg; uncontrolled diabetes: A1C\>7%;
9. Unwillingness/inability to take effective contraceptive measures during the trial period;
10. Female subjects have a positive blood pregnancy test;
11. Participated in a drug clinical trial within 3 months;
12. The investigator believes that it is not suitable for inclusion.

Primary outcomes:
measure: the changes of the size and extent of corneal neovascularization
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
Secondary outcomes:
measure: the changes of visual acuity
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
measure: the changes of intraocular pressure
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
measure: the changes of central corneal thickness
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
measure: the changes of conjunctival hyperemia score
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
measure: the changes of corneal fluorescein staining score
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal
measure: the changes of corneal sensation
timeFrame: Baseline and 4 weeks after drug withdrawal
measure: the morphological changes of corneal subepithelial nerve
timeFrame: Baseline and 4 weeks after drug withdrawal
measure: the changes of ocular tolerability score
timeFrame: 1 week, 2 weeks, 4 weeks and 6 weeks after medication
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-Sen University
Study officials:
References: