Corneal Neovascularization
Conditions
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.
Interventions
DRUGConbercept 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.
DRUGPlacebo
In the second stage, subjects will be receive Conbercept eys drop or a placebo.
Sponsors
Chengdu Kanghong Biotech Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactDeng Yingping
Outcome results
None listed