Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT i… (NCT03941587) | Clinical Trial Compass
CompletedNot Applicable
Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT in PCV Treatment
Singapore60 participantsStarted 2021-02-01
Plain-language summary
In this study, we aim to evaluate the efficacy and safety of an individualized dosing schedule comprising Aflibercept and RF-PDT in patients with polypoidal choroidal vasculopathy (PCV). The primary objective is to compare the polyp closure rate at week 12 between the 2 treatment groups. The secondary aims include comparing visual, anatomical, treatment burden and clinical biomarkers between each treatment group.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged over 50 years old at the time of informed consent.
* Provide written informed consent.
* Willingness and ability to comply with all scheduled visits and study procedures.
* Confirmed diagnosis of symptomatic macular PCV based ICGA.
* Activity of PCV confirmed by exudative activity involving the macula on OCT or Fluorescein Angiography (FA) or both.
* Presence of intra retinal or subretinal fluid/blood as seen on OCT
* Treatment naïve
* NO previous treatment with intravitreal anti-VEGF agents, regardless of the indication
* NO previous thermal laser in the macular region, or verteporfin photodynamic therapy (vPDT), regardless of indication
* NO other previous treatment for neovascular AMD (nAMD), except oral supplements and traditional Chinese medicine
* An ETDRS BCVA of at least 4 letters (Snellen equivalent approximately 20/800 or better) in the study eye.
* Greatest Linear Dimension (GLD) of the total lesion area (BVN + polyps) \<5400µm (\~9 mucopolysaccharidoses (MPS) Disc Areas) as delineated by ICGA.
Exclusion Criteria: - Participant
* Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
* Participation in an investigational trial within 30 days of enrollment which involves treatment with unapproved investigational drug.
* Known allergy to any component of the study…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.