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)

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: Recruiting
• Conditions: Polypoidal Choroidal Vasculopathy
• Intervention / Treatment: Diagnostic test: Indocyanine Green Angiography

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 (Estimated): 72

Contacts and Locations

• Study Contact: Name: Principal Investigator; Phone Number: 63227460; Email: gemmy.cheung.c.m@singhealth.com.sg
• Study Contact Backup: Name: co-Investigator; Phone Number: 63228378; Email: kelvin.teo.y.c@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Hospital
    • Contact: Caroline Chee, MBBS
  • Singapore, Singapore, 308433
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Rajesh Rajagopalan
  • Singapore, Singapore, 168751
    • Recruiting
    • Singapore National Eye Centre
    • Contact: Gemmy Cheung, MBBS; Phone Number: 6322 4500

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes	within 72 months

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Investigators: Principal Investigator: Principal Investigator, Singapore National Eye Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

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): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Eye Diseases; Disease Attributes; Uveal Diseases; Choroid Diseases; Metaplasia; Neovascularization, Pathologic; Choroidal Neovascularization; Vascular Diseases; Recurrence; Polypoidal Choroidal Vasculopathy
• 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