Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

Completed

• Conditions: Polypoidal Choroidal Vasculopathy; Conbercept

• Registration Number: NCT05229237
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-18
• Study Start: 2018-05-01
• Primary Completion: 2021-06-05
• Study Completion: 2021-12-05
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity	6 months after the first Conbercept treatment	Best corrected visual acuity using ETDRS chart (letter numbers)

Secondary Outcome Measures

Name	Time	Method
FFA&ICGA	12 months after the first Conbercept treatment	Changes of PCV lesions on ICGA (μm)
OCT and OCTA	12 months after the first Conbercept treatment	Changes of central retinal thickness and size of PED (μm)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China