Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

A Multicenter, Observational, Registrie Study of Conbercept in the Treatment of Polypoidal Choroidal Vasculopathy（START Study）

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.

Study Overview

• Status: Completed
• Conditions: Polypoidal Choroidal Vasculopathy; Conbercept
• Intervention / Treatment: Drug: Conbercept

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed as polypoid choroidal vasculopathy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Best corrected visual acuity using ETDRS chart (letter numbers)	6 months after the first Conbercept treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Youxin Chen, Professor, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Conbercept; Polypoidal Choroidal Vasculopathy; registration study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: STart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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