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

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.

Study Overview

• Status: Unknown
• Conditions: Corneal Neovascularization
• Intervention / Treatment: Drug: Conbercept eye drop; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Recruiting
      • Renmin Hospital of Wuhan University
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Deng yingping; Email: Dyp588@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.; Drug: Placebo; In the second stage, subjects will be receive Conbercept eys drop or a placebo.
Experimental: 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.	Drug: 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.; Drug: Placebo; In the second stage, subjects will be receive Conbercept eys drop or a placebo.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 25, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Corneal Diseases; Metaplasia; Neovascularization, Pathologic; Corneal Neovascularization; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: KH906-40101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No