Polypoidal Choroidal VasculopathyNCT03941587
Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT in PCV Treatment
A study testing Aflibercept + reduced fluence photodynamic therapy (RF-PDT) in people with Polypoidal Choroidal Vasculopathy, run by Singapore National Eye Centre at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- Aflibercept + reduced fluence photodynamic therapy (RF-PDT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Feb 2021to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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 drug.
- Blood pressure> 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
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- Amblyopia or blind in one eye Study Eye
- Eye with intra retinal or sub-retinal fluid due to other causes than PCV
- An ocular condition is present (other than PCV) that, in the opinion of the investigator, might affect intra or sub retinal fluid or alter visual acuity during the course of the study (e.g., Diabetic Macular Edema (DME), vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by more than three lines (i.e., cataract would be reducing acuity to worse than 20/40 if eye was otherwise normal).
- Any intraocular surgery within 1 month of enrollment
- Treatment with intra vitreal corticosteroids
- History of retinal detachment or surgery for retinal detachment
- History of vitrectomy
- History of macular hole
- Evidence of vitreomacular traction that may preclude resolution of macular edema \> 4 disc areas of intra/sub retinal hemorrhage
- Aphakia
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
- Other Eye
- Active intraocular inflammation
- History of uveitis
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore National Eye Centre
Singapore, Singapore, 168751
National University Hospital
Singapore
About this study
Official title: A Multi-center Randomized Clinical Trial Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT for the Treatment of Polypoidal Choroidal Vasculopathy
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.
Read the detailed description
Age related macular degeneration (AMD) is one of the leading causes of blindness worldwide. In its exudative or wet form, choroidal neovascularization (CNV) causes an exudative maculopathy resulting in sudden loss of vision with severe effects on patients' quality of life. Intravitreal injections of anti-vascular endothelial growth factor agents (anti-VEGF) have become the mainstay of treatment for AMD CNV and has been shown to have favorable outcomes in most AMD CNV subtypes. In the Asian population, however, a particular subtype called polypoidal choroidal vasculopathy (PCV), which affects about 50% of exudative maculopathy, has been shown to have less favorable response to anti-VEGF therapy.
The best treatment option for PCV has remained unclear. Current best evidence is from 2 recent randomized controlled trials, the EVEREST II trial which compares the efficacy of ranibizumab with or without photodynamic therapy (PDT) for treatment of PCV and the PLANET trial which compares Aflibercept monotherapy against a rescue PDT when Aflibercept is deemed ineffective. Both trials have reported significant improvement in visual outcomes, however there remain significant unanswered questions and unmet needs regarding the use of Aflibercept and PDT as the best treatment for PCV.
In this study, we aim to compare the efficacy of combination Aflibercept with RF-PDT (at baseline) and Aflibercept monotherapy. This particular strategy has not been studies before and represents the amalgamation of unanswered questions from the best evidence to date for the treatment of PCV.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- Aflibercept + reduced fluence photodynamic therapy (RF-PDT), Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept + reduced fluence photodynamic therapy (RF-PDT)Drug
Also called Eylea, Visudyne
Aflibercept dosage of 2mg in 0.05ml along with intravenous infusion of Verteporfin (6mg/m2)followed by laser light at a dosage of 25Joule/cm2
Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)Drug
Also called Eylea
Aflibercept dosage of 2mg in 0.05ml along with sham photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept + RF-PDT | Active comparator | Patients with symptomatic macular PCV (n=80) as confirmed by Indocyanine green Angiography(ICGA) will be treated with Aflibercept (dosage=2mg/0.05ml) through an intravitreal injection + RF-PDT ( 6mg/m2 intravenous infusion of Verteporfin followed by laser light at a dose rate of 25 Joules/cm2) at baseline.
Aflibercept- 1st treatment (baseline) followed by minimum retreatment interval of 4 weeks (from Baseline to week 8) and then retreatment at intervals of 4 weeks pro re nata (PRN) retreatment( week 12-48). Primary endpoint at week 52.
RF-PDT treatment at baseline followed by pro re nata (PRN) at 12 week intervals.
At each visit, subjects will be assessed based on BCVA, ophthalmic examination and Optical Coherence Tomography (OCT) Receives: Drug: Aflibercept + reduced fluence photodynamic therapy (RF-PDT) |
| Aflibercept + sham RF-PDT | Active comparator | Patients with symptomatic macular PCV (n=80) as confirmed by Indocyanine green Angiography(ICGA) will be treated with Aflibercept (dosage=2mg/0.05ml) through an intravitreal injection, at baseline. A minimum of 1 injection(baseline) followed by minimum pro re nata (PRN) retreatment interval of 4 weeks ( from baseline to week 8) and then a minimum of 4 weeks retreatment thereafter (week 12-48). Primary endpoint at week 52.
Sham RF-PDT treatment at baseline followed by pro re nata (PRN) at 12 week intervals.
At each visit, subjects will be assessed based on Best Corrected Visual Acuity (BCVA), ophthalmic examination and Optical Coherence Tomography (OCT) Receives: Drug: Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp Closure rate
polyp closure rate at week 12 between the 2 treatment groups.
Measured: 12 weeks
Secondary outcomes (6)
Optical Coherence Tomography
For evidence of intraretinal or subretinal fluid, ill-defined hyper-reflective material and/or new hemorrhage
Measured: 12 months
Optical Coherence Tomography-Angiograph
For evidence of intraretinal or subretinal fluid, ill-defined hyper-reflective material and/or new hemorrhage
Measured: 12 months
Color Fundus photography
inspect anomalies associated to diseases that affect the eye, and to monitor their progression
Measured: baseline, month 3, month12
Autofluorescence Photography
Retinal imaging
Measured: baseline, month 3, month12
Fundus Fluorescein Angiography
Retinal circulation
Measured: Baseline, month 3, month 12
Intra Ocular Pressure (IOP)
Fluid Pressure in eye
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Feb 2021
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polypoidal Choroidal VasculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center randomized, double-masked clinical trial.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- National University Hospital, Singapore, Tan Tock Seng Hospital
- Responsible party
- Principal investigator, Gemmy Cheung Chui Ming, Singapore National Eye Centre
- Investigators
- Gemmy Cheung Chui Ming, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941587
- Sponsor's protocol ID
- R1735/58/2020
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chong YJ, Teo KYC, Wong W, Tan ACS, Su X, Gilead N, Chan HH, Ibrahim F, Fenner B, Ong C, Sun C, Sim S, Chee C, Chakravarthy U, Cheung CMG. Aflibercept With vs Without Reduced-Fluence Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):393-399. doi: 10.1001/jamaophthalmol.2025.0250.
PubMed 40146166Vyas CH, Cheung CMG, Tan C, Chee C, Wong K, Jordan-Yu JMN, Wong TY, Tan A, Fenner B, Sim S, Teo KYC. Multicentre, randomised clinical trial comparing intravitreal aflibercept monotherapy versus aflibercept combined with reduced-fluence photodynamic therapy (RF-PDT) for the treatment of polypoidal choroidal vasculopathy. BMJ Open. 2021 Jul 15;11(7):e050252. doi: 10.1136/bmjopen-2021-050252.
PubMed 34266844
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Clinical Trial Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT for the Treatment of Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT03941587
- Acronym / sponsor ID
- R1735/58/2020
- Conditions
- Polypoidal Choroidal Vasculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- National University Hospital, Singapore, Tan Tock Seng Hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Age related macular degeneration (AMD) is one of the leading causes of blindness worldwide. In its exudative or wet form, choroidal neovascularization (CNV) causes an exudative maculopathy resulting in sudden loss of vision with severe effects on patients' quality of life. Intravitreal injections of anti-vascular endothelial growth factor agents (anti-VEGF) have become the mainstay of treatment for AMD CNV and has been shown to have favorable outcomes in most AMD CNV subtypes. In the Asian population, however, a particular subtype called polypoidal choroidal vasculopathy (PCV), which affects about 50% of exudative maculopathy, has been shown to have less favorable response to anti-VEGF therapy.
The best treatment option for PCV has remained unclear. Current best evidence is from 2 recent randomized controlled trials, the EVEREST II trial which compares the efficacy of ranibizumab with or without photodynamic therapy (PDT) for treatment of PCV and the PLANET trial which compares Aflibercept monotherapy against a rescue PDT when Aflibercept is deemed ineffective. Both trials have reported significant improvement in visual outcomes, however there remain significant unanswered questions and unmet needs regarding the use of Aflibercept and PDT as the best treatment for PCV.
In this study, we aim to compare the efficacy of combination Aflibercept with RF-PDT (at baseline) and Aflibercept monotherapy. This particular strategy has not been studies before and represents the amalgamation of unanswered questions from the best evidence to date for the treatment of PCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center randomized, double-masked clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Aflibercept + RF-PDT | Active comparator | Drug: Aflibercept + reduced fluence photodynamic therapy (RF-PDT)Patients with symptomatic macular PCV (n=80) as confirmed by Indocyanine green Angiography(ICGA) will be treated with Aflibercept (dosage=2mg/0.05ml) through an intravitreal injection + RF-PDT ( 6mg/m2 intravenous infusion of Verteporfin followed by laser light at a dose rate of 25 Joules/cm2) at baseline. Aflibercept- 1st treatment (baseline) followed by minimum retreatment interval of 4 weeks (from Baseline to week 8) and then retreatment at intervals of 4 weeks pro re nata (PRN) retreatment( week 12-48). Primary endpoint at week 52. RF-PDT treatment at baseline followed by pro re nata (PRN) at 12 week intervals. At each visit, subjects will be assessed based on BCVA, ophthalmic examination and Optical Coherence Tomography (OCT) |
| Aflibercept + sham RF-PDT | Active comparator | Drug: Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)Patients with symptomatic macular PCV (n=80) as confirmed by Indocyanine green Angiography(ICGA) will be treated with Aflibercept (dosage=2mg/0.05ml) through an intravitreal injection, at baseline. A minimum of 1 injection(baseline) followed by minimum pro re nata (PRN) retreatment interval of 4 weeks ( from baseline to week 8) and then a minimum of 4 weeks retreatment thereafter (week 12-48). Primary endpoint at week 52. Sham RF-PDT treatment at baseline followed by pro re nata (PRN) at 12 week intervals. At each visit, subjects will be assessed based on Best Corrected Visual Acuity (BCVA), ophthalmic examination and Optical Coherence Tomography (OCT) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (21 listed)
- 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 drug.
- Blood pressure> 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept + reduced fluence photodynamic therapy (RF-PDT)Also: Eylea, VisudyneAflibercept dosage of 2mg in 0.05ml along with intravenous infusion of Verteporfin (6mg/m2)followed by laser light at a dosage of 25Joule/cm2 | Drug | Aflibercept + RF-PDT |
| Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)Also: EyleaAflibercept dosage of 2mg in 0.05ml along with sham photodynamic therapy | Drug | Aflibercept + sham RF-PDT |
Primary outcome
Polyp Closure rate
Time frame: 12 weeks
polyp closure rate at week 12 between the 2 treatment groups.
6 secondary outcomes
Optical Coherence Tomography
Time frame: 12 months
Optical Coherence Tomography-Angiograph
Time frame: 12 months
Color Fundus photography
Time frame: baseline, month 3, month12
Autofluorescence Photography
Time frame: baseline, month 3, month12
Fundus Fluorescein Angiography
Time frame: Baseline, month 3, month 12
Intra Ocular Pressure (IOP)
Time frame: Baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 40146166Chong YJ, Teo KYC, Wong W, Tan ACS, Su X, Gilead N, Chan HH, Ibrahim F, Fenner B, Ong C, Sun C, Sim S, Chee C, Chakravarthy U, Cheung CMG. Aflibercept With vs Without Reduced-Fluence Photodynamic Therapy for Polypoidal Choroidal Vasculopathy: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 May 1;143(5):393-399. doi: 10.1001/jamaophthalmol.2025.0250.
- Derived from this study: PubMed 34266844Vyas CH, Cheung CMG, Tan C, Chee C, Wong K, Jordan-Yu JMN, Wong TY, Tan A, Fenner B, Sim S, Teo KYC. Multicentre, randomised clinical trial comparing intravitreal aflibercept monotherapy versus aflibercept combined with reduced-fluence photodynamic therapy (RF-PDT) for the treatment of polypoidal choroidal vasculopathy. BMJ Open. 2021 Jul 15;11(7):e050252. doi: 10.1136/bmjopen-2021-050252.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemmy Cheung Chui Ming principal investigator
Singapore National Eye Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aflibercept + reduced fluence photodynamic therapy (RF-PDT) in people with Polypoidal Choroidal Vasculopathy, run by Singapore National Eye Centre at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polyp Closure rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941587, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.