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

Study Overview
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Brief Summary
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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.

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

Conditions
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Corneal Neovascularization

Intervention / Treatment
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* Drug: Conbercept eye drop
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conbercept eye drop (0.1mg/ mL)<br>Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time. | Drug: Conbercept eye drop<br>* In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.<br>|
| Experimental: Conbercept eye drop (0.5mg/ mL)<br>Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time. | Drug: Conbercept eye drop<br>* In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.<br>Drug: Placebo<br>* In the second stage, subjects will be receive Conbercept eys drop or a placebo.<br>|
| Experimental: Conbercept eye drop (1.0mg/ mL)<br>Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time. | Drug: Conbercept eye drop<br>* In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.<br>Drug: Placebo<br>* In the second stage, subjects will be receive Conbercept eys drop or a placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |