Clinical trial NCT05229237: Conbercept for Polypoidal Choroidal Vasculopathy（START Study）
Official title: A Multicenter, Observational, Registrie Study of Conbercept in the Treatment of Polypoidal Choroidal Vasculopathy（START Study）
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polypoidal Choroidal Vasculopathy
Conbercept
Keywords: registration study
Polypoidal Choroidal Vasculopathy
Conbercept
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed as polypoid choroidal vasculopathy.

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.

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

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months after the first Conbercept treatment
Secondary outcomes:
measure: OCT and OCTA
timeFrame: 12 months after the first Conbercept treatment
measure: FFA&ICGA
timeFrame: 12 months after the first Conbercept treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Youxin Chen, Professor
role: STUDY_CHAIR
References: