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

Phase 1

• Conditions: Corneal Neovascularization
• Interventions: Drug: Conbercept eye drop; Drug: Placebo

• Registration Number: NCT04215393
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-18
• Status Verified: 2019-12
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-31
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02
• Primary Completion: 2020-04
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Conbercept eye drop (1.0mg/ mL)	Placebo	Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Conbercept eye drop (1.0mg/ mL)	Conbercept eye drop	Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Conbercept eye drop (0.5mg/ mL)	Placebo	Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Conbercept eye drop (0.1mg/ mL)	Conbercept eye drop	Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Conbercept eye drop (0.5mg/ mL)	Conbercept eye drop	Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.

Primary Outcome Measures

Name	Time	Method
Ocular and Systemic Safety: occurrence of ocular and systemic adverse events	day 14	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.

Secondary Outcome Measures

Name	Time	Method
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study	day 14 and day 28	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.

Trial Locations

Locations (2)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China