Corneal NeovascularizationPhase 1NCT04215393
An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization
A Phase 1 study testing Conbercept eye drop in people with Corneal Neovascularization, run by Chengdu Kanghong Biotech Co., Ltd. at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- Conbercept eye drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jul 2019to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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）.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Deng yingping, Dyp588@163.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
About this study
Official title: An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization
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.
- Conditions
- Corneal Neovascularization
- Being tested
- Conbercept eye drop, Placebo
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conbercept eye dropDrug
In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.
PlaceboDrug
In the second stage, subjects will be receive Conbercept eys drop or a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Conbercept eye drop (0.1mg/ mL) | Experimental | Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time. Receives: Drug: Conbercept eye drop |
| Conbercept eye drop (0.5mg/ mL) | Experimental | Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time. Receives: Drug: Conbercept eye drop; Drug: Placebo |
| Conbercept eye drop (1.0mg/ mL) | Experimental | Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time. Receives: Drug: Conbercept eye drop; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 14
Secondary outcomes (1)
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.
Measured: day 14 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start18 Jul 2019
- Primary completionApr 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal NeovascularizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215393
- Sponsor's protocol ID
- KH906-40101
- Status last verified
- Dec 2019
- First submitted
- 25 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization
- ClinicalTrials.gov ID
- NCT04215393
- Acronym / sponsor ID
- KH906-40101
- Conditions
- Corneal Neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conbercept eye drop (0.1mg/ mL) | Experimental | Drug: Conbercept eye dropSubjects 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) | Experimental | Drug: Conbercept eye drop, Drug: PlaceboSubjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time. |
| Conbercept eye drop (1.0mg/ mL) | Experimental | Drug: Conbercept eye drop, Drug: PlaceboSubjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conbercept eye dropIn the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo. | Drug | Conbercept eye drop (0.1mg/ mL), Conbercept eye drop (0.5mg/ mL), Conbercept eye drop (1.0mg/ mL) |
| PlaceboIn the second stage, subjects will be receive Conbercept eys drop or a placebo. | Drug | Conbercept eye drop (0.5mg/ mL), Conbercept eye drop (1.0mg/ mL) |
Primary outcome
Ocular and Systemic Safety: occurrence of ocular and systemic adverse events
Time frame: 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.
1 secondary outcome
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study
Time frame: day 14 and day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conbercept eye drop in people with Corneal Neovascularization, run by Chengdu Kanghong Biotech Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deng Yingping (18980601736, Dyp558@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular and Systemic Safety: occurrence of ocular and systemic adverse events (time frame: day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.