Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03929731 |
| Other study ID # |
R1597/96/2018 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 5, 2019 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Singapore National Eye Centre |
| Contact |
Principal Investigator |
| Phone |
63227460 |
| Email |
gemmy.cheung.c.m[@]singhealth.com.sg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
