An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization
NCT ID: NCT04215393
Last Updated: 2020-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
39 participants
INTERVENTIONAL
2019-07-18
2020-12-31
Brief Summary
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The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Conbercept eye drop (0.1mg/ mL)
Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.
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.
Conbercept eye drop (0.5mg/ mL)
Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.
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.
Conbercept eye drop (1.0mg/ mL)
Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Ages from 18 to 75,male or female.
* Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chengdu Kanghong Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Renmin Hospital of Wuhan University
Wuhan, Hubei, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KH906-40101
Identifier Type: -
Identifier Source: org_study_id
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