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

Primary Purpose

Corneal Neovascularization

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Conbercept eye drop
Placebo
Sponsored by
Chengdu Kanghong Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Corneal Neovascularization

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Renmin Hospital of Wuhan UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conbercept eye drop (0.1mg/ mL)

Conbercept eye drop (0.5mg/ mL)

Conbercept eye drop (1.0mg/ mL)

Arm Description

Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.

Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.

Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 25, 2019
Last Updated
December 31, 2019
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04215393
Brief Title
An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization
Official Title
An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conbercept eye drop (0.1mg/ mL)
Arm Type
Experimental
Arm Description
Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Arm Title
Conbercept eye drop (0.5mg/ mL)
Arm Type
Experimental
Arm Description
Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Arm Title
Conbercept eye drop (1.0mg/ mL)
Arm Type
Experimental
Arm Description
Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
Intervention Type
Drug
Intervention Name(s)
Conbercept eye drop
Intervention Description
In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
In the second stage, subjects will be receive Conbercept eys drop or a placebo.
Primary Outcome Measure Information:
Title
Ocular and Systemic Safety: occurrence of ocular and systemic adverse events
Description
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.
Time Frame
day 14
Secondary Outcome Measure Information:
Title
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study
Description
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.
Time Frame
day 14 and day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deng Yingping
Phone
18980601736
Email
Dyp558@163.com
Facility Information:
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deng yingping
Email
Dyp588@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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