Polypoidal Choroidal VasculopathyNCT00383812
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
A study testing Intravitreal Bevacizumab in people with Polypoidal Choroidal Vasculopathy, run by Asan Medical Center at 1 site in South Korea.
Trial summary
1. Primary objectives a. To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV) 2. Secondary objectives 1. To assess the changes in visual acuity 2. To assess the change in lesion characteristics of PCV size of PCV fluorescein leakage foveal thickness 3. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Intravitreal Bevacizumab
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2006to May 2008
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, CNV secondary to PCV
- BCVA of 20/40 to 20/320 (Snellen equivalent)
- Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss)
Who cannot join
- Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity
- Media opacity in the study eye that precludes clinical and photographic evaluation
- Intraocular surgery < 1 month before day 0
- Use of heparin/warfarin within 1 month prior to injection
- Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine
- Contraindication to pupil dilation in either eye
- Any condition which precludes patients' ability to comply with study requirements including completion of the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
About this study
- Primary objectives
- To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV)
- Secondary objectives
- To assess the changes in visual acuity
- To assess the change in lesion characteristics of PCV
- size of PCV
- fluorescein leakage
- foveal thickness
- To investigate the safety of intravitreal Bevacizumab in patients with PCV
- To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Intravitreal Bevacizumab
- Keywords
- Polypoidal choroidal vasculopathy, Intravitreal Bevacizumab
- 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.
Intravitreal BevacizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.
To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse
Secondary outcomes (2)
To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT)
To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startMay 2006
- Study completionMay 2008
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 Asan Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Young Hee Yoon, MD, Principal investigator, Asan Medical CenterJune-Gone Kim, MD, Principal investigator, Asan Medical CenterSun Young Lee, MD, Principal investigator, Asan Medical CenterHyewon Chung, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383812
- Sponsor's protocol ID
- Bevacizumab for PCV
- Status last verified
- Oct 2006
- First submitted
- 3 Oct 2006
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT00383812
- Acronym / sponsor ID
- Bevacizumab for PCV
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- Polypoidal choroidal vasculopathy, Intravitreal Bevacizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- May 2006
- Study completion
- May 2008
- First posted
- 4 Oct 2006 (estimated)
- 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.
- Primary objectives
- To evaluate the Effects of intravitreal Bevacizumab on polypoidal choroidal vasculopathy(PCV)
- Secondary objectives
- To assess the changes in visual acuity
- To assess the change in lesion characteristics of PCV
- size of PCV
- fluorescein leakage
- foveal thickness
- To investigate the safety of intravitreal Bevacizumab in patients with PCV
- To assess the effect of intravitreal Bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with PCV
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, CNV secondary to PCV
- BCVA of 20/40 to 20/320 (Snellen equivalent)
- Evidence of presumed recent disease progression (blood, growth by FA, or recent VA loss)
Key exclusion criteria (7 listed)
- Uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity
- Media opacity in the study eye that precludes clinical and photographic evaluation
- Intraocular surgery < 1 month before day 0
- Use of heparin/warfarin within 1 month prior to injection
- Known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine
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 |
|---|---|---|
| Intravitreal Bevacizumab | Drug | – |
Primary outcome
To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.
To assess the percentage of patients whose final visual acuity resulted in Snellen equivalent of 20/200 or worse
2 secondary outcomes
To investigate the resolution time of macular edema, subretinal fluid, and/or pigment epithelial detachment (PED) using optical coherence tomography (OCT)
To evaluate change in size and leakage of PCV, using fluorescein angiography (FA) and/or indocyanine angiography (ICGA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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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.
Young Hee Yoon, MD principal investigator
Asan Medical Center
June-Gone Kim, MD principal investigator
Asan Medical Center
Sun Young Lee, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal Bevacizumab in people with Polypoidal Choroidal Vasculopathy, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 7 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 4 Oct 2006. 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 South Korea. 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 Sun Young Lee, MD (82-2-3010-3970, sunylee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the percentage of patients who gained an improvement in best corrected visual acuity (BCVA) by 15 letters of more.. 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 4 Oct 2006; AzTrials last refreshed its copy on 6 Nov 2026.