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

NCT ID: NCT05011916

Last Updated: 2021-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2022-08-09

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.

Conditions

Corneal Neovascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Patients in the control group received 0.1% fluorometholone eye drops (0.1% fluorometholone + 0.05% tacrolimus eye drops for patients after corneal transplantation). The patients applied 0.1% fluorometholone eye drops 4 times daily for 10 weeks. Patients were instructed to continue with their usual ophthalmic medication regimens, such as topical antibacterial and antiviral drugs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low-concentration group

Patients in the low-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group.

Group Type: EXPERIMENTAL

KDR2-2 suspension eye drops

Intervention Type: DRUG

All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.

Medium-concentration group

Patients in the medium-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group.

Group Type: EXPERIMENTAL

KDR2-2 suspension eye drops

Intervention Type: DRUG

All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.

High-concentration group

Patients in the High-concentration group applied 4mg/ml KDR2-2 suspension eye drops 4 times daily for 6 weeks. The rest of the medication regimen is the same as the control group.

Group Type: EXPERIMENTAL

KDR2-2 suspension eye drops

Intervention Type: DRUG

All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.

Interventions

KDR2-2 suspension eye drops

All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Opthalmic Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Wang, PhD

Role: CONTACT

419059130@qq.com

18843014719

Jin Yuan, PhD

Role: CONTACT

yuanjincornea@163.com

13825141659

Facility Contacts

Yuan Jin, Professor

Role: primary

yuanjincornea@126.com

8602087333391

Qian Wang, MD

Role: primary

419059130@qq.com

86-018843014719

Other Identifiers

2021KYPJ139

Identifier Type: -

Identifier Source: org_study_id