Conbercept for Polypoidal Choroidal Vasculopathy（START St... | NCT05229237

Studies
Conbercept for Polypoidal Choroidal Vasculopathy（START Study）

NCT05229237

Sponsor

Peking Union Medical College Hospital

Status

Completed

Last Update Posted

Feb 8, 2022Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Polypoidal Choroidal Vasculopathy
Conbercept

Interventions

Conbercept

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

Jun 5, 2021Actual

Completion Date

Dec 5, 2021Actual

First Submitted Date

Apr 18, 2018

First Submission Date that Met QC Criteria

Feb 7, 2022

First Posted Date

Feb 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2022

Last Update Posted Date

Feb 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Name	Type	Description	Arm Group Labels	Other Names
Conbercept	Drug	Intravitral injection of Conbercept (0.5 mg/0.05 mL, Chengdu Kanghong Biotech, Inc.)		This was no other intervention name

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity	Best corrected visual acuity using ETDRS chart (letter numbers)	6 months after the first Conbercept treatment

Secondary Outcomes

Measure	Description	Time Frame
OCT and OCTA	Changes of central retinal thickness and size of PED (μm)	12 months after the first Conbercept treatment
FFA&ICGA	Changes of PCV lesions on ICGA (μm)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients diagnosed as polypoid choroidal vasculopathy.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Youxin Chen, Professor	Peking Union Medical College Hospital	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D020256	Choroidal Neovascularization
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases