An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization

Corneal Neovascularization Clinical Trial

Official title:

An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215393
• Other study ID #: KH906-40101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 18, 2019
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: Chengdu Kanghong Biotech Co., Ltd.
• Contact: Deng Yingping
• Phone: 18980601736
• Email: Dyp558[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization.

The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: December 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed the informed consent form, volunteered to participate in the trial and followed up according to the protocol.

• Ages from 18 to 75,male or female.

• Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.

Exclusion Criteria:

• Subjects who had significant defect in the corneal epithelium.

• Study eye had been injected of anti-vegf drugs within 3 months before screening

• Study eye was performed surgery (except keratoplasty) within 3 months prior screening, or eye surgery was planned during this trial period.

• Oral glucocorticoid administration within 1 month prior screening (except for duration less than 7 days)

• Systemic use of anti-vegf drugs within 45 days prior to screening.

• Have history of abnormal coagulation, such as end-stage liver disease, or are taking anticoagulants(except aspirin).

• Uncontrolled clinical problems such as canner etc..

• Unable or unwilling to use effective contraception.

• Positive blood tests for pregnancy (female subjects)

• Participated in drug clinical trials within 3 months before the first administration.

• The researchers think the participants were not suitable for this trail.

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Conbercept eye drop
In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.
• Placebo
In the second stage, subjects will be receive Conbercept eys drop or a placebo.

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Kanghong Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular and Systemic Safety: occurrence of ocular and systemic adverse events	The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations. Systemic adverse events were identified with physical examinations.	day 14
Secondary	The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study	The efficacy of KH906 in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.	day 14 and day 28