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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
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:
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).
Disease characteristics of the study eye assessed by the investigator including:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypoidal Choroidal Vasculopathy RCT | Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green Angiography | Diagnostic Test | Intravenous injection of dye-indocyanine green |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Singapore National Eye Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Singapore | Singapore | 168751 | Singapore | ||
| Tan Tock Seng Hospital |
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| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005451 | Fluorescein Angiography |
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D000792 | Angiography |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Singapore |
| Singapore |
| 308433 |
| Singapore |
| National University Hospital | Singapore | Singapore |
| D009389 |
| Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D014054 | Tomography |
| D008919 | Investigative Techniques |