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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Comparing Intravitreal Brolucizumab Monotherapy vs Aflibercept Monotherapy in PCV Treatment

Clinicaltrials.gov identifier NCT03941587

Recruitment Status Not yet recruiting

First Posted May 8, 2019

Last update posted July 29, 2020

Study Description

Brief summary:

In this study, we aim to compare the efficacy and safety of a practical individualized pro re nata treatment regimen between Brolucizamab and Aflibercept in patients with polypoidal choroidal vasculopathy (PCV).

  • Condition or Disease:Polypoidal Choroidal Vasculopathy
  • Intervention/Treatment: Drug: Aflibercept
    Drug: Brolucizumab
  • Phase: N/A
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 favourable 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 favourable response to anti-VEGF therapy. The best treatment option for PCV has remained unclear. Having favorable visual outcomes, anti-VEGF monotherapy has superseded photodynamic therapy as an effective first line of treatment for PCV.3,4 The non-inferiority of intravitreal (IVT) Aflibercept monotherapy vs combined therapy in terms of mean change in visual acuity from baseline to 1 year was well described in a pivotal randomized control trial, the PLANET study in 2018.5 In the recent released results of the Hawk and Harrier Study (2019), Brolucizumab, a novel anti-VEGF therapy, showed non-inferior clinical results compared to Aflibercept therapy in patients with neovascularAMD. In this study, a 3 monthly loading dose was given and a treat and extend protocol was followed. Visual function was found to be comparable between treatment arms while, anatomical outcomes were significantly better with Brolucizumab. Though anti-VEGF therapy has improved visual outcomes in the treatment of PCV, frequent clinic visits, injection visits as well as cost has remained to be a burdensome unmet need for patients diagnosed with PCV. A need for a more sustainable and cost-effective treatment regimen should therefore be studied to provide a practical solution for this unmet need. A multi-centred randomised controlled trial would give the best evidence in comparing the 2 treatment modalities.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 160 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Multi-center randomized, double-masked clinical trial.
  • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multi-centre Double-blind Randomized Clinical Trial Comparing Intravitreal Brolucizumab Monotherapy vs Aflibercept Monotherapy in the Treatment of Polypoidal Choroidal Vasculopathy
  • Estimated Study Start Date: October 2020
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: December 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Aflibercept Monotherapy
Patients with symptomatic macular PCV (n=80) as confirmed by Indocyanine green Angiography(ICGA) will be treated with a dose of Aflibercept 2mg/0.05ml through an intravitreal injection,at baseline. A minimum of 1 injection(baseline) followed by Pro re nata (PRN) with minimum retreatment interval of 4 weeks ( from baseline to week 8) and then a minimum of 8 weeks retreatment thereafter ( week 12-52). Primary endpoint at week 52. At each visit, subjects will be assessed based on Best Corrected Visual Acuity (BCVA), opthalmic examination, Optical Coherence Tomography (OCT) and Optical Coherence Tomography-Angiography (OCT-A).
Drug: Aflibercept
Aflibercept dosage of 2mg in 0.05ml
Active Comparator: Brolucizumab Monotherapy
Patients with symptomatic macular PCV (n=80) as confirmed by Indocyanine green Angiography(ICGA) will be treated with a dose of 6mg/ 0.05ml of Brolucizumab through an intravitreal injection, at baseline. A minimum of 1 injection(baseline) followed by PRN with minimum retreatment interval of 4 weeks ( from Baseline to week 8) and then minimum of 8 weeks retreatment thereafter ( week 12-52). Primary endpoint at week 52. At each visit, subjects will be assessed based on BCVA, opthalmic examination, Optical Coherence Tomography (OCT) and Optical Coherence Tomography-Angiography (OCT-A).
Drug: Brolucizumab
Brolucizumab dosage of 6mg in 0.05ml
Outcome Measures
  • Primary Outcome Measures: 1. Visual Acuity change [ Time Frame: 12 months ]
    Loss of ≥ 5 letters from Best Corrected Visual Acuity since baseline
  • Secondary Outcome Measures: 1. Optical Coherence Tomography [ Time Frame: 12 months ]
    For evidence of intraretinal or subretinal fluid, ill-defined hyper-reflective material and/or new hemorrhage
  • 2. Optical Coherence Tomography-Angiograph [ Time Frame: 12 months ]
    For evidence of intraretinal or subretinal fluid, ill-defined hyper-reflective material and/or new hemorrhage
  • 3. Color fundus photography [ Time Frame: baseline, month 3, month12 ]
    inspect anomalies associated to diseases that affect the eye, and to monitor their progression
  • 4. Autofluorescence Photography [ Time Frame: baseline, month 3, month12 ]
    Retinal imaging
Eligibility Criteria
  • Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Gemmy Cheung Chui Ming 63227460 gemmy.cheung.c.m@singhealth.com.sg

Contact: Kelvin Teo Yi Chong

Locations

Singapore
Singapore National Eye Centre
Singapore

Singapore
National University Hospital
Singapore

Singapore
Tan Tock Seng Hospital
Singapore

Sponsors and Collaborators

Singapore National Eye Centre

National University Hospital, Singapore

Tan Tock Seng Hospital

Investigators

Principal Investigator: Gemmy Cheung Chui Ming Singapore National Eye Centre

More Information
  • Responsible Party: Singapore National Eye Centre
  • ClinicalTrials.gov Identifier: NCT03941587 History of Changes
  • Other Study ID Numbers: R1544/43/2018
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: July 29, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Vascular Diseases