Polypoidal Choroidal VasculopathyNCT05639660
Clinical Implication of Aflibercept in PCV Treatment in China
An observational study of Polypoidal Choroidal Vasculopathy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- non-interventional
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Nov 2024
- How long will I take part?
- 1 Year
- 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 18 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
- Age ≥ 18 years, gender, unilateral or bilateral onset
- Treatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examination
- Signed informed consent, able to long-term follow-up
- PCV patients previously treated with aflibercept were enrolled as retrospective cases, and PCV patients previously treated with other anti-VEGF, at least 1 month since the last treatment
Who cannot join
- Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucoma
- Received oral or intravenous antiangiogenic drugs within 180 days prior to the screening visit
- The study eye has a history of idiopathic or autoimmune uveitis
- Study eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitis
- The patient has a coagulation disorder or is taking oral warfarin, Plavix (clopidogrel) and other similar anticoagulation drugs.
- The patient is receiving treatment for severe systemic infection
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- Patients with uncontrolled blood pressure (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg when the subject is sitting)
- Cerebrovascular accident and/or myocardial infarction within 180 days prior to the screening visit
- Patients with renal insufficiency undergoing renal dialysis, renal failure requiring dialysis or renal transplantation
- The investigator believes that based on the history of other diseases, metabolic dysfunction, physical examination results or clinical laboratory results, patients have a disease or condition that will increase the risk for complications from treatment
- Pregnant or lactating women; women of childbearing potential with positive pregnancy test results at baseline or not receiving pregnancy test; postmenopausal women must have been amenorrhea for at least 12 months to not be considered fertile
- Participated in any drug (except vitamins and minerals) or device therapy study within 30 days prior to the screening visit
- The patient has received other anti-VEGF therapy within 30 days
- Other patients deemed necessary to be excluded by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Chen Youxin, Professor, 010-69156114, chenyouxinpumch@163.com
About this study
Official title: Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study
The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. This study is a long-term follow-up cohort, plans to unite a total of 30 hospitals in different regions of the China to enroll 1000 PCV patients.
Main evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.
Read the detailed description
Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s)
- To describe the treatment regimens of aflibercept treatment on PCV in clinical practice.
- To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED)
- To explore the relative factors of aflibercept treatment effectiveness.
- To describe patients' tolerance to anti-VEGF and PDT treatment.
- To collect safety information with aflibercept treatment in a wider population setting
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- non-interventional
- Keywords
- Polypoidal Choroidal Vasculopathy, Aflibercept
- 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.
non-interventionalOther
The treatment guideline recommends the 3+Q2m regimen for Aflibercept, but this study is an observational study, no intervention is made in the subjects' treatment regimen. There is no prescribed visit plan. According to the decision of the doctor and the patient according to the treatment plan, the patient needs to come to the clinic within the prescribed time window (3, 6, and 12 months) to facilitate the recording of data.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept group | Single arm, Aflibercept 2.0mg/0.05ml, intravitreal injection Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mean BCVA from baseline at the month 3, 6, 12
Routine International standard visual acuity chart, best corrected visual acuity
Measured: Through study completion, 1 year
Mean treatment pattern of aflibercept in PCV treatment
To describe the mean treatment pattern of aflibercept in PCV treatment
Measured: Through study completion, 1 year
Secondary outcomes (8)
Proportion of patients with each treatment regimen
based on different count and describe the patients' proportion
Measured: Through study completion, 1 year
Change in CRT from baseline at month 3, 6, 12
Non-contact intraocular pressure before and after study eye injection, study eye slit lamp, ophthalmoscopy, identify the change of CRT
Measured: Through study completion, 1 year
Proportion of patients with complete regression of polyps at month 3, 6, 12
color fundus photography of the research eye, study eye ICGA angiography
Measured: Through study completion, 1 year
Proportion of patients with inactivity polyps at month 3, 6, 12
color fundus photography of the research eye, study eye ICGA angiography
Measured: Through study completion, 1 year
Proportion of patients with dry retina at month 3, 6 and 12
OCT, OCTA examination, color fundus photography of the research eye
Measured: Through study completion, 1 year
Proportion of patients with PED regression at month 3, 6 and 12
OCT, OCTA examination
Measured: Through study completion, 1 year
Mean of treatment interval and number of injections at month 12
Observe and describe the treatment pattern during routine follow-up visits
Measured: Through study completion, 1 year
Inactive polyp evaluation by OCTA at month 3, 6, 12
OCTA examination during follow-up visits
Measured: Through study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Jan 2021
- Primary completion20 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Youxin Chen, Professor, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639660
- Sponsor's protocol ID
- CAPTAIN
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study
- ClinicalTrials.gov ID
- NCT05639660
- Acronym / sponsor ID
- CAPTAIN
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- Polypoidal Choroidal Vasculopathy, Aflibercept
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 6 Dec 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.
The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. This study is a long-term follow-up cohort, plans to unite a total of 30 hospitals in different regions of the China to enroll 1000 PCV patients.
Main evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.
Detailed description
Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s)
- To describe the treatment regimens of aflibercept treatment on PCV in clinical practice.
- To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED)
- To explore the relative factors of aflibercept treatment effectiveness.
- To describe patients' tolerance to anti-VEGF and PDT treatment.
- To collect safety information with aflibercept treatment in a wider population setting
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept group | – | Other: non-interventionalSingle arm, Aflibercept 2.0mg/0.05ml, intravitreal injection |
Who may qualify
- Ages
- 18 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 (4 listed)
- Age ≥ 18 years, gender, unilateral or bilateral onset
- Treatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examination
- Signed informed consent, able to long-term follow-up
- PCV patients previously treated with aflibercept were enrolled as retrospective cases, and PCV patients previously treated with other anti-VEGF, at least 1 month since the last treatment
Key exclusion criteria (14 listed)
- Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucoma
- Received oral or intravenous antiangiogenic drugs within 180 days prior to the screening visit
- The study eye has a history of idiopathic or autoimmune uveitis
- Study eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitis
- The patient has a coagulation disorder or is taking oral warfarin, Plavix (clopidogrel) and other similar anticoagulation drugs.
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 |
|---|---|---|
| non-interventionalThe treatment guideline recommends the 3+Q2m regimen for Aflibercept, but this study is an observational study, no intervention is made in the subjects' treatment regimen. There is no prescribed visit plan. According to the decision of the doctor and the patient according to the treatment plan, the patient needs to come to the clinic within the prescribed time window (3, 6, and 12 months) to facilitate the recording of data. | Other | Aflibercept group |
Primary outcome
Change of Mean BCVA from baseline at the month 3, 6, 12
Time frame: Through study completion, 1 year
Routine International standard visual acuity chart, best corrected visual acuity
Mean treatment pattern of aflibercept in PCV treatment
Time frame: Through study completion, 1 year
To describe the mean treatment pattern of aflibercept in PCV treatment
8 secondary outcomes
Proportion of patients with each treatment regimen
Time frame: Through study completion, 1 year
Change in CRT from baseline at month 3, 6, 12
Time frame: Through study completion, 1 year
Proportion of patients with complete regression of polyps at month 3, 6, 12
Time frame: Through study completion, 1 year
Proportion of patients with inactivity polyps at month 3, 6, 12
Time frame: Through study completion, 1 year
Proportion of patients with dry retina at month 3, 6 and 12
Time frame: Through study completion, 1 year
Proportion of patients with PED regression at month 3, 6 and 12
Time frame: Through study completion, 1 year
Mean of treatment interval and number of injections at month 12
Time frame: Through study completion, 1 year
Inactive polyp evaluation by OCTA at month 3, 6, 12
Time frame: Through study completion, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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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, 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youxin Chen, Professor (+86 13801025972, chenyx@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Mean BCVA from baseline at the month 3, 6, 12 (time frame: Through study completion, 1 year). The study lists 2 primary outcomes in all. 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 6 Dec 2022.