Polypoidal Choroidal Vasculopathy Without Active PolypPhase 4NCT02072408
Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy
A Phase 4 study testing aflibercept in people with Polypoidal Choroidal Vasculopathy Without Active Polyp, run by Samsung Medical Center at 3 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy Without Active Polyp
- What is being tested?
- aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2014to 2 Nov 2017
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- polypoidal choroidal vasculopathy without active polyp
- decreased visual acuity by subretinal fluid and hemorrhage involving foveal center
Who cannot join
- polypoidal choroidal vasculopathy with active polyp
- previous photodynamic therapy more than three times
- anti-VEGF injection within one month
- photodynamic therapy or intraocular steroid treatment within three months
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do
Konyang University Kim's Eye Hospital
Seoul
Samsung Medical Center
Seoul
About this study
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.
- Being tested
- aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afliberceptDrug
- Three monthly intravitreal aflibercept (2mg) injections
- Five bimonthly intravitreal aflibercept (2mg) injections
- Rescue treatment: Verteporfin photodynamic therapy
- Loss of five ETDRS letters or one Snellen line of vision from baseline
- Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection
- Presence of active polyp on indocyanine green angiography
| Study group | Role | What they receive |
|---|---|---|
| polypoidal choroidal vasculopathy without polyp | Experimental | Not described Receives: Drug: aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of best-corrected visual acuity (ETDRS letters)
Measured: 1 year
Secondary outcomes (5)
presence of subretinal hemorrhage
Total number of months when subretinal hemorrhage are detected on fundus photographs.
Measured: during 1 year
presence of fluid in macula evidenced by optical coherence tomography
Total number of months when fluid in macula are detected on optical coherence tomography
Measured: during 1 year
change of indocyanine green angiography
Change of indocyanine green angiography will include followings
- New appearance of polypoidal structure
- Any change in size of the greatest linear dimension of lesion
- Any change in size and activity of branching vascular network
Measured: during 1 year
Number of eyes which need rescue treatment (photodynamic therapy)
In this study, photodynamic therapy will be performed as a rescue therapy according to the necessary criteria.
Measured: during 1 year
safety outcomes
frequency and severity of ocular adverse event
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal Vasculopathy Without Active PolypStudies of the same condition, open and under way.
- More trials run by Samsung 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Kim's Eye Hospital, Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072408
- Sponsor's protocol ID
- 2013-10-044-002
- Status last verified
- Feb 2014
- First submitted
- 10 Feb 2014
- Last updated
- 5 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravitreal Vascular Endothelial Growth Factor Trap-eye in Patients With Polyploidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT02072408
- Acronym / sponsor ID
- 2013-10-044-002
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Kim's Eye Hospital, Bayer
- Study start
- Feb 2014
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 26 Feb 2014 (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.
The purpose of this study is to evaluate the efficacy and safety of aflibercept for treatment of polypoidal choroidal vasculopathy without active polyp.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polypoidal choroidal vasculopathy without polyp | Experimental | Drug: aflibercept |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- polypoidal choroidal vasculopathy without active polyp
- decreased visual acuity by subretinal fluid and hemorrhage involving foveal center
Key exclusion criteria (4 listed)
- polypoidal choroidal vasculopathy with active polyp
- previous photodynamic therapy more than three times
- anti-VEGF injection within one month
- photodynamic therapy or intraocular steroid treatment within three months
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 |
|---|---|---|
| aflibercept1. Three monthly intravitreal aflibercept (2mg) injections 2. Five bimonthly intravitreal aflibercept (2mg) injections 3. Rescue treatment: Verteporfin photodynamic therapy * Loss of five ETDRS letters or one Snellen line of vision from baseline * Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection * Presence of active polyp on indocyanine green angiography | Drug | polypoidal choroidal vasculopathy without polyp |
Primary outcome
Change of best-corrected visual acuity (ETDRS letters)
Time frame: 1 year
5 secondary outcomes
presence of subretinal hemorrhage
Time frame: during 1 year
presence of fluid in macula evidenced by optical coherence tomography
Time frame: during 1 year
change of indocyanine green angiography
Time frame: during 1 year
Number of eyes which need rescue treatment (photodynamic therapy)
Time frame: during 1 year
safety outcomes
Time frame: one year
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 5 Sep 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aflibercept in people with Polypoidal Choroidal Vasculopathy Without Active Polyp, run by Samsung Medical Center at 3 sites 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 2 inclusion and 4 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of best-corrected visual acuity (ETDRS letters) (time frame: 1 year). 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 5 Sep 2018.