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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore National Eye Centre
• Collaborators: National University Hospital, Singapore; Tan Tock Seng Hospital
• Treatments: Aflibercept; Verteporfin

Criteria

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 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 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) <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 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 > 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