Polypoidal Choroidal VasculopathyNCT03929731
Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy (PCV)
An observational study of Polypoidal Choroidal Vasculopathy, run by Singapore National Eye Centre at 3 sites in Singapore.
Trial summary
To determine long-term outcomes, recurrence rates, and treatment needs in Polypoidal Choroidal Vasculopathy (PCV). Specifically, to describe the long-term outcomes, recurrence rates and treatment patterns PCV patients 5 years after first presentation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Indocyanine Green Angiography
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 3 sitesSingapore
- Study dates
- 5 Jul 2019to 9 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies
Who may be able to join
- Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies
- Are able to give consent for this follow up study
Who cannot join
- No exclusion criteria unless they do not meet the inclusion criteria
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites
Singapore National Eye Centre
Singapore, Singapore, 168751
Tan Tock Seng Hospital
Singapore, Singapore, 308433
National University Hospital
Singapore
About this study
Official title: To Determine Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy(PCV)
To determine long-term outcomes, recurrence rates, and treatment needs in Polypoidal Choroidal Vasculopathy (PCV). Specifically, to describe the long-term outcomes, recurrence rates and treatment patterns PCV patients 5 years after first presentation. This study will also evaluate whether polyp closure within the first 12 months of therapy is associated with better long-term visual outcome and will also determine the risk of disease development in the fellow eye
Read the detailed description
The investigators will conduct a non-interventional, observational cohort study to assess the visual outcome of patients who have completed one of three recent randomized controlled trials in Polypoidal Choroidal Vasculopathy (PCV) EVERESTII, PLANET, PCV Treat and Extend (T\&E) study. After completion of the randomized controlled trails (2 years for EVEREST II and PLANET; 1 year for T\&E study), patients will be released from clinical trial protocol. At approximately 6 years (2019-2024), patients will be contacted by research coordinators and invited to attend a follow-up examination.
Study Design:
Non-interventional, observational, cohort study
Clinical coordinators will contact patients of:
- EVEREST II (2013-2015)
- PLANET (2014-2015)
- PCV T\&E (2018-2019) at ~72 +/- 6 months after their initial baseline visits (2019-2024) Study Visits and Procedures Participants will only be expected to attend 1 evaluation clinic which will last approximately 3 hours
Contact of prior trial participants Participants from prior randomized control trials (EVEREST II, PLANET and PCV T\&E) will be contacted by phone and invited to attend 1 post-trial evaluation clinic.
Historical Information A history will be elicited from the participant and extracted from available medical records.
Data to be collected will include: age, gender, ethnicity and race, past medical history and medications being used, as well as ocular diseases, surgeries, and treatment.
An assessment of visual related quality of life will be performed using the impact of visual impairment (IVI) questionnaire.
Testing Procedures The following procedures will be performed (using the study technique and by delegated personnel) as part of usual care, it does not need to be repeated specifically for the study if it was performed within the defined time (within 14 days prior to visit).
- Best-corrected Visual Acuity (BCVA) will be measured using the ETDRS VA protocol following manifest refraction.
- Optical Coherence Tomography/ OCT Angiography: OCT and OCTA will be performed. Both standard and enhanced depth imaging scans will be performed.
- Ocular examination on each eye including slit lamp, measurement of intra-ocular pressure, lens assessment, and dilated ophthalmoscopy.
- Fundus Photography
- Fundus fluorescein and Indocyanine Green angiography: FFA and ICGA will be performed.
Disease characteristics of the study eye assessed by the investigator including:
- Activity of PCV based on ICGA.
- Presence of activity clinically as evidence by presence of hemorrhage, edema.
- Presence of activity as evidence by intra retinal or sub retinal fluid on OCT. The clinical data from the exit of trial to this visit will be accessed from medical records both paper- based and electronic formats.
All the data collected from this visit, data from the prior trial and the clinical course and treatment from the end of the trial to this visit will be anonymized and sent to the Singapore Eye Research Institution (SERI) for analysis. Only the principal investigator and study team at site and SERI will have access to the anonymized collected information.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Indocyanine Green Angiography
- 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.
Indocyanine Green AngiographyDiagnostic test
Also called Optical Coherence Tomography-Angiography, Fundus photography, Fundus fluorescein, Optical Coherence Tomography
Intravenous injection of dye-indocyanine green
| Study group | Role | What they receive |
|---|---|---|
| Polypoidal Choroidal Vasculopathy RCT | Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies Receives: Diagnostic Test: Indocyanine Green Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term prognostication
Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes
Measured: within 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start5 Jul 2019
- Primary completion9 May 2024
- Study completion9 May 2024
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.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gemmy Cheung Chui Ming, Singapore National Eye Centre
- Investigators
- Principal Investigator, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929731
- Sponsor's protocol ID
- R1597/96/2018
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy(PCV)
- ClinicalTrials.gov ID
- NCT03929731
- Acronym / sponsor ID
- R1597/96/2018
- Conditions
- Polypoidal Choroidal Vasculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 29 Apr 2019 (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 determine long-term outcomes, recurrence rates, and treatment needs in Polypoidal Choroidal Vasculopathy (PCV). Specifically, to describe the long-term outcomes, recurrence rates and treatment patterns PCV patients 5 years after first presentation. This study will also evaluate whether polyp closure within the first 12 months of therapy is associated with better long-term visual outcome and will also determine the risk of disease development in the fellow eye
Detailed description
The investigators will conduct a non-interventional, observational cohort study to assess the visual outcome of patients who have completed one of three recent randomized controlled trials in Polypoidal Choroidal Vasculopathy (PCV) EVERESTII, PLANET, PCV Treat and Extend (T\&E) study. After completion of the randomized controlled trails (2 years for EVEREST II and PLANET; 1 year for T\&E study), patients will be released from clinical trial protocol. At approximately 6 years (2019-2024), patients will be contacted by research coordinators and invited to attend a follow-up examination.
Study Design:
Non-interventional, observational, cohort study
Clinical coordinators will contact patients of:
- EVEREST II (2013-2015)
- PLANET (2014-2015)
- PCV T\&E (2018-2019) at ~72 +/- 6 months after their initial baseline visits (2019-2024) Study Visits and Procedures Participants will only be expected to attend 1 evaluation clinic which will last approximately 3 hours
Contact of prior trial participants Participants from prior randomized control trials (EVEREST II, PLANET and PCV T\&E) will be contacted by phone and invited to attend 1 post-trial evaluation clinic.
Historical Information A history will be elicited from the participant and extracted from available medical records.
Data to be collected will include: age, gender, ethnicity and race, past medical history and medications being used, as well as ocular diseases, surgeries, and treatment.
An assessment of visual related quality of life will be performed using the impact of visual impairment (IVI) questionnaire.
Testing Procedures The following procedures will be performed (using the study technique and by delegated personnel) as part of usual care, it does not need to be repeated specifically for the study if it was performed within the defined time (within 14 days prior to visit).
- Best-corrected Visual Acuity (BCVA) will be measured using the ETDRS VA protocol following manifest refraction.
- Optical Coherence Tomography/ OCT Angiography: OCT and OCTA will be performed. Both standard and enhanced depth imaging scans will be performed.
- Ocular examination on each eye including slit lamp, measurement of intra-ocular pressure, lens assessment, and dilated ophthalmoscopy.
- Fundus Photography
- Fundus fluorescein and Indocyanine Green angiography: FFA and ICGA will be performed.
Disease characteristics of the study eye assessed by the investigator including:
- Activity of PCV based on ICGA.
- Presence of activity clinically as evidence by presence of hemorrhage, edema.
- Presence of activity as evidence by intra retinal or sub retinal fluid on OCT. The clinical data from the exit of trial to this visit will be accessed from medical records both paper- based and electronic formats.
All the data collected from this visit, data from the prior trial and the clinical course and treatment from the end of the trial to this visit will be anonymized and sent to the Singapore Eye Research Institution (SERI) for analysis. Only the principal investigator and study team at site and SERI will have access to the anonymized collected information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polypoidal Choroidal Vasculopathy RCT | – | Diagnostic Test: Indocyanine Green AngiographyParticipants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies
Key inclusion criteria (2 listed)
- Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies
- Are able to give consent for this follow up study
Key exclusion criteria (1 listed)
- No exclusion criteria unless they do not meet the inclusion criteria
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 |
|---|---|---|
| Indocyanine Green AngiographyAlso: Optical Coherence Tomography-Angiography, Fundus photography, Fundus fluorescein, Optical Coherence TomographyIntravenous injection of dye-indocyanine green | Diagnostic test | Polypoidal Choroidal Vasculopathy RCT |
Primary outcome
Long term prognostication
Time frame: within 72 months
Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Principal Investigator principal investigator
Singapore National Eye Centre
3 sites 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 Singapore National Eye Centre at 3 sites in Singapore.
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 1 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 18 Nov 2025. 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 Singapore. 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?
Long term prognostication (time frame: within 72 months). 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 18 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.