Polypoidal Choroidal VasculopathyNCT05229237
Conbercept for Polypoidal Choroidal Vasculopathy（START Study）
An observational study of Polypoidal Choroidal Vasculopathy and Conbercept, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy, Conbercept
- What is being tested?
- Conbercept
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 5 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed as polypoid choroidal vasculopathy.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Observational, Registrie Study of Conbercept in the Treatment of Polypoidal Choroidal Vasculopathy（START Study）
- 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.
Read the 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.
- Conditions
- Polypoidal Choroidal Vasculopathy, Conbercept
- Being tested
- Conbercept
- Keywords
- registration study, Polypoidal Choroidal Vasculopathy, Conbercept
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConberceptDrug
Also called This was no other intervention name
Intravitral injection of Conbercept (0.5 mg/0.05 mL, Chengdu Kanghong Biotech, Inc.)
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Best corrected visual acuity using ETDRS chart (letter numbers)
Measured: 6 months after the first Conbercept treatment
Secondary outcomes (2)
OCT and OCTA
Changes of central retinal thickness and size of PED (μm)
Measured: 12 months after the first Conbercept treatment
FFA&ICGA
Changes of PCV lesions on ICGA (μm)
Measured: 12 months after the first Conbercept treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 May 2018
- Primary completion5 Jun 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal VasculopathyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youxin Chen, Professor, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229237
- Sponsor's protocol ID
- START
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational, Registrie Study of Conbercept in the Treatment of Polypoidal Choroidal Vasculopathy（START Study）
- ClinicalTrials.gov ID
- NCT05229237
- Acronym / sponsor ID
- START
- Conditions
- Polypoidal Choroidal Vasculopathy, Conbercept
- Keywords
- registration study, Polypoidal Choroidal Vasculopathy, Conbercept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed as polypoid choroidal vasculopathy.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConberceptAlso: This was no other intervention nameIntravitral injection of Conbercept (0.5 mg/0.05 mL, Chengdu Kanghong Biotech, Inc.) | Drug | – |
Primary outcome
Visual acuity
Time frame: 6 months after the first Conbercept treatment
Best corrected visual acuity using ETDRS chart (letter numbers)
2 secondary outcomes
OCT and OCTA
Time frame: 12 months after the first Conbercept treatment
FFA&ICGA
Time frame: 12 months after the first Conbercept treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youxin Chen, Professor study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polypoidal Choroidal Vasculopathy and Conbercept, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 6 months after the first Conbercept treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.