Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

NCT ID: NCT05229237

Last Updated: 2022-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-12-05

Brief Summary

1. To evaluate the effectiveness of Conbercept for PCV patients.

2. To describe the characteristics of PCV.

3. To describe the adverse events (AE) of Conbercept in the treatment of PCV.

4. Todescirbe the real situation and prognosis of PCV patients in our country.

Detailed Description

1. To observe the visual changes in PCV patients receiving Conbercept treatment, so as to evaluate the effectiveness of the treatment. Changes of OCT, ICGA, quality of life and visual function would be observed and evaluated.

2. To observe and describe the characteristics of PCV.

3. To observe and describe the incidence of adverse events (AE) and serious adverse events (SAE) of Conbercept in the treatment of PCV, so as to evaluate the safety of this treatment.

4. To observe and descirbe the real situation and prognosis of PCV patients in our country.

Conditions

Polypoidal Choroidal Vasculopathy; Conbercept

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Conbercept

Intravitral injection of Conbercept (0.5 mg/0.05 mL, Chengdu Kanghong Biotech, Inc.)

Intervention Type: DRUG

Other Intervention Names

This was no other intervention name

Eligibility Criteria

Inclusion Criteria

• According to the current diagnostic criteria, diagnosed as PCV patients
• Conbercept is used for treatment, and the recommended treatment scheme is 3+PRN
• Local and systemic anti-VEGF therapy was not used for at least three months before enrollment
• The patient volunteers to take part in this observational study, and signs the informed consent
• The patient can follow-up regularly (at least 4 times of follow-up in one year)

Exclusion Criteria

• The patient has serious systemic disease, and the current clinical treatment is contraindicated
• Local or systemic anti-VEGF therapy was used for less than three months before enrollment
• Existence of diseases unsuitable to accept intravitreal Conbercept, including uncontrolled hypertension and diabetes, AIDS, malignant tumors, active hepatitis, severe renal failure, severe mental, nerve, cardiovascular, respiratory and immune diseases
• During six months before screening, there were cardiovascular events such as stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure
• Ocular contraindications, including active intraocular inflammation, infectious endophthalmitis, corneal ulcer, scleritis, uncontrolled glaucoma and so on
• Patients who could not follow up regularly
• Patients who refuse to sign the informed consent
• Others

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Youxin Chen, Professor

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Countries

China

Other Identifiers

START

Identifier Type: -

Identifier Source: org_study_id