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

Overview

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

Full Title of Study: “To Determine Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy(PCV)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2023

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.

Interventions

  • Diagnostic Test: Indocyanine Green Angiography
    • Intravenous injection of dye-indocyanine green

Arms, Groups and Cohorts

  • Polypoidal Choroidal Vasculopathy RCT
    • Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Singapore National Eye Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gemmy Cheung Chui Ming, Assistant Professor – Singapore National Eye Centre
  • Overall Official(s)
    • Principal Investigator, Principal Investigator, Singapore National Eye Centre
  • Overall Contact(s)
    • Principal Investigator, 63227460, gemmy.cheung.c.m@singhealth.com.sg

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.