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

NCT04215393 | Unknown Phase 1

• 1 other identifier: KH906-40101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

Corneal Neovascularization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

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.

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.

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.

Drug: Conbercept eye drop; Drug: Placebo

Interventions

Conbercept eye drop DRUG

In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.

Conbercept eye drop (0.1mg/ mL); Conbercept eye drop (0.5mg/ mL); Conbercept eye drop (1.0mg/ mL)

Placebo DRUG

In the second stage, subjects will be receive Conbercept eys drop or a placebo.

Conbercept eye drop (0.5mg/ mL); Conbercept eye drop (1.0mg/ mL)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

Study Sites (2)

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Corneal Neovascularization

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Deng Yingping

CONTACT

18980601736; Dyp558@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: January 2, 2020
• Study Start: July 18, 2019
• Primary Completion: April 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)