Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

NCT05229237 | Completed DMC

• 1 other identifier: START
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the effectiveness of Conbercept for PCV patients.
2. 2.To describe the characteristics of PCV.
3. 3.To describe the adverse events (AE) of Conbercept in the treatment of PCV.
4. 4.Todescirbe the real situation and prognosis of PCV patients in our country.

Conditions

Polypoidal Choroidal Vasculopathy; Conbercept

Keywords

registration study; Polypoidal Choroidal Vasculopathy; Conbercept

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Best corrected visual acuity using ETDRS chart (letter numbers)

  6 months after the first Conbercept treatment

Secondary Outcomes (2)

• OCT and OCTA

  12 months after the first Conbercept treatment

• FFA&ICGA

  12 months after the first Conbercept treatment

Interventions

Conbercept DRUG

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

Also known as: This was no other intervention name

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed as polypoid choroidal vasculopathy.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

KH902 fusion protein

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Youxin Chen, Professor

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: February 8, 2022
• Study Start: May 1, 2018
• Primary Completion: June 5, 2021
• Study Completion: December 5, 2021
• Last Updated: February 8, 2022

Record last verified: 2018-04

Locations

CN (1)