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

Kanghong Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Corneal Neovascularization

Treatments: Drug: Placebo; Drug: Conbercept eye drop

Study type: Interventional

Funder types: Industry

Identifiers

NCT04215393

KH906-40101

Details and patient eligibility

About

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.

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Conbercept eye drop (0.1mg/ mL)

Experimental group

Description:

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

Treatment:

Drug: Conbercept eye drop

Conbercept eye drop (0.5mg/ mL)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Conbercept eye drop

Conbercept eye drop (1.0mg/ mL)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Conbercept eye drop