Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT in PCV Treatment

NCT03941587 | Completed DMC

• 1 other identifier: R1735/58/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Polypoidal Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

• Polyp Closure rate

  polyp closure rate at week 12 between the 2 treatment groups.

  12 weeks

Secondary Outcomes (6)

• Optical Coherence Tomography

  12 months

• Optical Coherence Tomography-Angiograph

  12 months

• Color Fundus photography

  baseline, month 3, month12

• Autofluorescence Photography

  baseline, month 3, month12

• Fundus Fluorescein Angiography

  Baseline, month 3, month 12

Study Arms (2)

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)

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)

Drug: Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)

Interventions

Aflibercept + reduced fluence photodynamic therapy (RF-PDT) DRUG

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

Also known as: Eylea, Visudyne

Aflibercept + RF-PDT

Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT) DRUG

Aflibercept dosage of 2mg in 0.05ml along with sham photodynamic therapy

Also known as: Eylea

Aflibercept + sham RF-PDT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• National University Hospital, Singapore: collaborator
• Tan Tock Seng Hospital: collaborator

Study Sites (2)

Singapore National Eye Centre

Singapore, Singapore, 168751, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

• 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.

  PMID: 40146166 DERIVED

• Vyas 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.

  PMID: 34266844 DERIVED

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

aflibercept; Verteporfin

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Gemmy Cheung Chui Ming

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multi-center randomized, double-masked clinical trial.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 8, 2019
• Study Start: February 1, 2021
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: November 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)