Polypoidal Choroidal VasculopathyNCT02597855
Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy
An observational study of Polypoidal Choroidal Vasculopathy, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Aflibercept and Indocyanine green angiography (intraveonus indocyanine green dye)
- Type of treatment
- Injection or infusion
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Aug 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients were recruited from the retinal clinic of the Yeungnam university hospital. Recruitment started on October 01 2015 to March 31 2016.
Who may be able to join
- symptomatic typical PCV accompanying branch vascular network involving subfoveal area
- signed informed consent; and
- over 6 months follow-up period after enrollment.
Who cannot join
- retinal diseases other than PCV
- extrafoveal PCV not involving subfoveal area
- massive subretinal hemorrhage blocking polypoidal lesion on ICGA
- severe media opacity such as senile cataract
- previous history of intravitreal injection
- previous intraocular surgery history except cataract surgery which was done more than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy
Read the detailed description
The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Aflibercept, Indocyanine green angiography (intraveonus indocyanine green dye)
- 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.
AfliberceptDrug
Also called Eylea
Total 4 times of intravitreal aflibercept injection was performed
Indocyanine green angiography (intraveonus indocyanine green dye)Drug
At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 polypoidal choroidal vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. Receives: Drug: Aflibercept; Drug: Indocyanine green angiography (intraveonus indocyanine green dye) | |
| Type 2 polypoidal choroidal vasculopathy | Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. Receives: Drug: Aflibercept; Drug: Indocyanine green angiography (intraveonus indocyanine green dye) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression Rate of Polyp on Indocyanine Green Angiography
Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.
Measured: 3 months
Secondary outcomes (1)
Best Corrected Visual Acuity
Best corrected visual acuity assessed at baseline, 3 months, and 6 months
Measured: baseline, 3 months, and 6 monthsc
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polypoidal Choroidal VasculopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Sagong, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597855
- Sponsor's protocol ID
- YUMC2015-08-036
- Status last verified
- Jul 2016
- First submitted
- 3 Nov 2015
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jeong S, Sagong M. Short-term efficacy of intravitreal aflibercept depending on angiographic classification of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2017 Jun;101(6):758-763. doi: 10.1136/bjophthalmol-2016-309144. Epub 2016 Sep 5.
PubMed 27597740
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT02597855
- Acronym / sponsor ID
- YUMC2015-08-036
- Conditions
- Polypoidal Choroidal Vasculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 17 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy
Detailed description
The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 polypoidal choroidal vasculopathy | – | Drug: Aflibercept, Drug: Indocyanine green angiography (intraveonus indocyanine green dye)Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. |
| Type 2 polypoidal choroidal vasculopathy | – | Drug: Aflibercept, Drug: Indocyanine green angiography (intraveonus indocyanine green dye)Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients were recruited from the retinal clinic of the Yeungnam university hospital. Recruitment started on October 01 2015 to March 31 2016.
Key inclusion criteria (3 listed)
- symptomatic typical PCV accompanying branch vascular network involving subfoveal area
- signed informed consent; and
- over 6 months follow-up period after enrollment.
Key exclusion criteria (6 listed)
- retinal diseases other than PCV
- extrafoveal PCV not involving subfoveal area
- massive subretinal hemorrhage blocking polypoidal lesion on ICGA
- severe media opacity such as senile cataract
- previous history of intravitreal injection
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 |
|---|---|---|
| AfliberceptAlso: EyleaTotal 4 times of intravitreal aflibercept injection was performed | Drug | Type 1 polypoidal choroidal vasculopathy, Type 2 polypoidal choroidal vasculopathy |
| Indocyanine green angiography (intraveonus indocyanine green dye)At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure. | Drug | Type 1 polypoidal choroidal vasculopathy, Type 2 polypoidal choroidal vasculopathy |
Primary outcome
Regression Rate of Polyp on Indocyanine Green Angiography
Time frame: 3 months
Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.
1 secondary outcome
Best Corrected Visual Acuity
Time frame: baseline, 3 months, and 6 monthsc
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27597740Jeong S, Sagong M. Short-term efficacy of intravitreal aflibercept depending on angiographic classification of polypoidal choroidal vasculopathy. Br J Ophthalmol. 2017 Jun;101(6):758-763. doi: 10.1136/bjophthalmol-2016-309144. Epub 2016 Sep 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Yeungnam University College of Medicine 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 6 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 18 Aug 2016. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Regression Rate of Polyp on Indocyanine Green Angiography (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597855, which also lists 1 linked publication.
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 18 Aug 2016.