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

November 14, 2025 updated by: Gemmy Cheung Chui Ming, Singapore National Eye Centre

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Intravenous injection of dye-indocyanine green
Other Names:
  • Optical Coherence Tomography
  • Optical Coherence Tomography-Angiography
  • Fundus photography
  • Fundus fluorescein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term prognostication
Time Frame: within 72 months
Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes
within 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Investigators

  • Principal Investigator: Principal Investigator, Singapore National Eye Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2019

Primary Completion (Actual)

May 9, 2024

Study Completion (Actual)

May 9, 2024

Study Registration Dates

First Submitted

April 24, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1597/96/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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