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

NCT05011916 | Unknown Phase 1

• 1 other identifier: 2021KYPJ139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• the changes of the size and extent of corneal neovascularization

  The efficacy of KDR2-2 eye drops treatment on corneal neovascularization was evaluated by comparing corneal anterior segment photographs acquired at baseline with photographs acquired on the follow-up visits. Size and extent of CNV was investigated by four primary metrics: (1) neovascular area ratio, the ration of the area of the neovascularization to the area of the cornea, (2) vessel length (VL), the total length of the vessels projected into the cornea, (3) vessel caliber, the mean diameter of the corneal vessels, and (4) Corneal neovascularization progression/stabilization/regression rate

  Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal

Secondary Outcomes (8)

• the changes of visual acuity

  Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal

• the changes of intraocular pressure

  Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal

• the changes of central corneal thickness

  Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal

• the changes of conjunctival hyperemia score

  Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal

• the changes of corneal fluorescein staining score

  Baseline, 1 week, 2 weeks, 4 weeks and 6 weeks after medication, and 4 weeks after drug withdrawal

Study Arms (4)

Control group

NO INTERVENTION

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.

Low-concentration group

EXPERIMENTAL

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.

Drug: KDR2-2 suspension eye drops

Medium-concentration group

EXPERIMENTAL

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.

Drug: KDR2-2 suspension eye drops

High-concentration group

EXPERIMENTAL

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.

Drug: KDR2-2 suspension eye drops

Interventions

KDR2-2 suspension eye drops DRUG

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

High-concentration group; Low-concentration group; Medium-concentration group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• voluntarily participate in the trial, sign the informed consent form, and follow up according to the time specified by the trial;
• \~75 years old, without gender limit;
• 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.

You may not qualify if:

• Obvious corneal epithelial defects (\>1mm), or a history of persistent corneal epithelial defects in the past 3 months (\>1mm, ≥14 days);
• 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;
• Recent eye surgery (except for keratoplasty) within 3 months, or planned eye surgery during the trial period;
• Systemic use of glucocorticoid drugs, or intraocular or periocular injection of glucocorticoid drugs within 1 month;
• Contact lenses use within the past 2 weeks (except bandage lenses);
• Stable corneal neovascularization: \> 6 months;
• 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);
• 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%;
• Unwillingness/inability to take effective contraceptive measures during the trial period;
• Female subjects have a positive blood pregnancy test;
• Participated in a drug clinical trial within 3 months;

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (2)

Zhongshan Opthalmic Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, 510060, China

RECRUITING

MeSH Terms

Conditions

Corneal Neovascularization

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qian Wang, PhD

CONTACT

18843014719; 419059130@qq.com

Jin Yuan, PhD

CONTACT

13825141659; yuanjincornea@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 4

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 18, 2021
• Study Start: August 10, 2021
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

CN (2)