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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03941587
Recruitment Status Not yet recruiting
First Posted May 8, 2019
Last update posted July 29, 2020
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).
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 Having favorable visual outcomes, anti-VEGF monotherapy has superseded photodynamic therapy as an effective first line of treatment for PCV.3,4 The non-inferiority of intravitreal (IVT) Aflibercept monotherapy vs combined therapy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.
|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).
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).
Brolucizumab dosage of 6mg in 0.05ml
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- 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
- 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
- Exam evidence of external ocular infection, including conjunctivitis, chalazion, or
- Active intraocular inflammation
- History of uveitis
Contact: Gemmy Cheung Chui Ming 63227460 email@example.com
Singapore National Eye Centre
National University Hospital
Tan Tock Seng Hospital
Singapore National Eye Centre
National University Hospital, Singapore
Tan Tock Seng Hospital
Principal Investigator: Gemmy Cheung Chui Ming Singapore National Eye Centre