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Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05229237
Collaborator
(none)
500
Enrollment
1
Location
43.2
Actual Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Multicenter, Observational, Registrie Study of Conbercept in the Treatment of Polypoidal Choroidal Vasculopathy（START Study）
Actual Study Start Date :
May 1, 2018
Actual Primary Completion Date :
Jun 5, 2021
Actual Study Completion Date :
Dec 5, 2021

Outcome Measures

Primary Outcome Measures

  1. Visual acuity [6 months after the first Conbercept treatment]

    Best corrected visual acuity using ETDRS chart (letter numbers)

Secondary Outcome Measures

  1. OCT and OCTA [12 months after the first Conbercept treatment]

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

  2. FFA&ICGA [12 months after the first Conbercept treatment]

    Changes of PCV lesions on ICGA (μm)

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing China

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05229237
Other Study ID Numbers:
  • START
First Posted:
Feb 8, 2022
Last Update Posted:
Feb 8, 2022
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital
registration study
Polypoidal Choroidal Vasculopathy
Conbercept
Additional relevant MeSH terms:
Vascular Diseases

Study Results

No Results Posted as of Feb 8, 2022