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

  • STATUS
    Recruiting
  • End date
    May 31, 2022
  • participants needed
    160
  • sponsor
    Singapore National Eye Centre
Updated on 10 June 2021

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 objective is to compare the visual improvement from baseline to month 12, in eyes with PCV treated with Aflibercept monotherapy versus combination of Aflibercept with reduced fluence photodynamic therapy (RF-PDT)

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.

Details
Condition Polypoidal Choroidal Vasculopathy
Treatment Aflibercept + reduced fluence photodynamic therapy (RF-PDT), Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)
Clinical Study IdentifierNCT03941587
SponsorSingapore National Eye Centre
Last Modified on10 June 2021

Eligibility

Yes No Not Sure

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 at the fovea as seen on OCT
Treatment nave
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 4 to 73 letters (Snellen equivalent approximately 20/32 to 20/800) in the study eye
Greatest Linear Dimension (GLD) of the total lesion area (BVN + polyps) <5400m (~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 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 3 months 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 &gt; 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
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