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OpenTrials
Completed

NCT Number: NCT05229237

Conbercept for 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, China

About this study

  • 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.
  • To observe and describe the characteristics of PCV.
  • 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.
  • To observe and descirbe the real situation and prognosis of PCV patients in our country.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conbercept

Drug

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

Other names: This was no other intervention name

Primary outcomes

  1. Visual acuity

    Time frame: 6 months after the first Conbercept treatment

    Best corrected visual acuity using ETDRS chart (letter numbers)

Secondary outcomes

  1. OCT and OCTA

    Time frame: 12 months after the first Conbercept treatment

    Changes of central retinal thickness and size of PED (μm)

  2. FFA&ICGA

    Time frame: 12 months after the first Conbercept treatment

    Changes of PCV lesions on ICGA (μm)

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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