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CompletedNCT03929731Updated Nov 18, 2025

Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy (PCV)

An observational study in Polypoidal Choroidal Vasculopathy, sponsored by Singapore National Eye Centre. Completed at 3 sites in Singapore. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Singapore National Eye Centre · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Sex
All
01

Study 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. 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).

  1. Best-corrected Visual Acuity (BCVA) will be measured using the ETDRS VA protocol following manifest refraction.
  2. Optical Coherence Tomography/ OCT Angiography: OCT and OCTA will be performed. Both standard and enhanced depth imaging scans will be performed.
  3. Ocular examination on each eye including slit lamp, measurement of intra-ocular pressure, lens assessment, and dilated ophthalmoscopy.
  4. Fundus Photography
  5. 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.

02

Conditions studied

  • Polypoidal Choroidal Vasculopathy
03

In context

Polypoidal Choroidal Vasculopathy

54 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 6 are open to participants now.

This study's enrollment of 72 is below the median of 135 across 13 observational studies indexed under Polypoidal Choroidal Vasculopathy.

Browse Polypoidal Choroidal Vasculopathy studies →

Lead sponsor

Singapore National Eye Centre is the lead sponsor of 87 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • No exclusion criteria unless they do not meet the inclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (actual)
Patient registry
No

Groups and cohorts

  • Polypoidal Choroidal Vasculopathy RCT

    Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T\&E studies

    Diagnostic Test: Indocyanine Green Angiography

Interventions

  • Diagnostic testIndocyanine Green Angiography

    Intravenous injection of dye-indocyanine green

    Also known as: Optical Coherence Tomography-Angiography, Fundus photography, Fundus fluorescein, Optical Coherence Tomography

06

What researchers measure

Primary outcomes

  1. Long term prognostication

    Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes

    Time frame: within 72 months

07

Study locations

3 sites
  • Singapore National Eye Centre
    Singapore, Singapore 168751, Singapore
  • Tan Tock Seng Hospital
    Singapore, Singapore 308433, Singapore
  • National University Hospital
    Singapore, Singapore
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in May 2024, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2019
First posted
Apr 29, 2019
StartActual
Jul 5, 2019
Primary completionActual
May 9, 2024
CompletionActual
May 9, 2024
Last update
Nov 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03929731
Lead sponsor
Singapore National Eye Centre
Responsible party
Gemmy Cheung Chui Ming (Professor, Singapore National Eye Centre) — Principal investigator
First posted
Apr 29, 2019
Start date
Jul 5, 2019
Primary completion
May 9, 2024
Completion
May 9, 2024
Last update
Nov 18, 2025

Study contacts

Principal Investigator
principal investigator · Singapore National Eye Centre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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