Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229237
• Other study ID #: START
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: December 5, 2021

Study information

• Verified date: April 2018
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 5, 2021
• Est. primary completion date: June 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conbercept
• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Best corrected visual acuity using ETDRS chart (letter numbers)	6 months after the first Conbercept treatment
Secondary	OCT and OCTA	Changes of central retinal thickness and size of PED (µm)	12 months after the first Conbercept treatment
Secondary	FFA&ICGA	Changes of PCV lesions on ICGA (µm)	12 months after the first Conbercept treatment