A Phase 3 interventional study of Brolucizumab 6mg and Brolucizumab 6mg in Macular Polypoidal Choroidal Vasculopathy (PCV), sponsored by Novartis Pharmaceuticals. Completed at 15 sites in South Korea. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
This study is a 60-week, two-arm, randomized, open-label, active-controlled, multi-center study in patients with Polypoidal choroidal vasculopathy (PCV) who have not previously received anti-Vascular endothelial growth factor (VEGF) treatment.
The purpose of this study is to measure the change in Best-corrected visual acuity (BCVA) with brolucizumab 6 mg Personalized regimen compared with Brolucizumab 6 mg Standard q12w/q8w regimen in participants with Polypoidal choroidal vasculopathy (PCV).
In the Personalized regimen arm, the first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If there is no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the Treat-and-extend (T\&E) phase thereafter. In the T\&E phase, the treatment interval can be extended by 4 weeks at a time based on Investigator's judgment of visual and/or anatomic outcomes. The maximal treatment interval is 16 weeks. At the Investigator's discretion, a participant with no disease activity or improvement of disease activity (e.g., reduction of fluid) may also be maintained on the same interval. If disease activity recurs, the interval should be shortened by 4 weeks at a time or to a minimal interval of 8 weeks.
In the Standard q12w/q8w regimen arm, all participants will receive three loading injections every 4 weeks. After loading injection, participants with no disease activity at Week 16 will receive study treatment q12w at Week 20, Week 32, and Week 44. If there is disease activity at any scheduled treatment visit, the study intervals will be adjusted to 8 weeks thereafter. Treatment intervals can be increased to 12 weeks after a treatment visit with no disease activity.
54 studies on the registry are indexed under Polypoidal Choroidal Vasculopathy; 6 are open to participants now.
This study's enrollment of 148 is above the median of 50 across 39 interventional studies indexed under Polypoidal Choroidal Vasculopathy.
Browse Polypoidal Choroidal Vasculopathy studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants ≥ 50 years of age at Screening.
Study eye:
Exclusion Criteria:
Ocular conditions:
Total area of subretinal hemorrhage larger than 9 DA (Disc Area) or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye.
Ocular treatments in the study eye:
Macular laser photocoagulation (focal/grid) or Photodynamic therapy (PDT) at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline.
Systemic conditions or treatments:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1\~3 x 4-week loading injections and one 8-week injection, followed by Treat-and-extend (T\&E) regimen up to Week 56
Drug: Brolucizumab 6mg
3 x 4-week loading injections and disease activity assessment at week 16 followed by q12w/q8w up to Week 56
Drug: Brolucizumab 6mg
Brolucizumab 6mg (intravitreal) Personalized regimen arm: 1\~3 x 4-week loading injections and one 8-week injection, followed by Treat-and-extend (T\&E) regimen up to Week 56
Also known as: Beovu
Brolucizumab 6mg(intravitreal) Standard q12w/q8w regimen arm: 3 x 4-week loading injections and disease activity assessment at week 16 followed by q12w/q8w up to Week 56
Also known as: Beovu
Average change in Best Corrected Visual Acuity (BCVA) from Baseline at a period from Week 48 to Week 60
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: from Week 48 to Week 60
Number of participants with last completed treatment interval of 12 weeks and/or 16-weeks with no disease activity at a period from Week 48 to Week 60
As assessed by: BCVA with ETDRS charts Anatomical retinal evaluation of Spectral Domain Optical Coherence Tomography (SD-OCT) images Color fundus photography (CFP) and vascular leakage evaluation by Fluorescein angiography (FA) Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA)
Time frame: Week 12, Week 16, and from Week 48 to Week 60
Distribution of last completed treatment interval with no disease activity up to Week60
As assessed by: BCVA with ETDRS charts Anatomical retinal evaluation of Spectral Domain Optical Coherence Tomography (SD-OCT) images Color fundus photography (CFP) and vascular leakage evaluation by Fluorescein angiography (FA) Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA)
Time frame: up to Week 60
Distribution of the maximal intervals with no disease activity up to Week 60
As assessed by: BCVA with ETDRS charts Anatomical retinal evaluation of Spectral Domain Optical Coherence Tomography (SD-OCT) images Color fundus photography (CFP) and vascular leakage evaluation by Fluorescein angiography (FA) Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA)
Time frame: up to Week 60
Distribution of the last interval at a period from Week 48 to Week 60
As assessed by: BCVA with ETDRS charts Anatomical retinal evaluation of Spectral Domain Optical Coherence Tomography (SD-OCT) images Color fundus photography (CFP) and vascular leakage evaluation by Fluorescein angiography (FA) Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA)
Time frame: from Week 48 to Week 60
Time from the last loading injection to the first visit with no disease activity
As assessed by: BCVA with ETDRS charts Anatomical retinal evaluation of Spectral Domain Optical Coherence Tomography (SD-OCT) images Color fundus photography (CFP) and vascular leakage evaluation by Fluorescein angiography (FA) Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA)
Time frame: Up to Week 60
Occurrence of at least two successive treatment intervals with no disease activity ≥ 12-week or two successive treatment intervals with no disease activity of 16-week up to Week 60
As assessed by: BCVA with ETDRS charts Anatomical retinal evaluation of Spectral Domain Optical Coherence Tomography (SD-OCT) images Color fundus photography (CFP) and vascular leakage evaluation by Fluorescein angiography (FA) Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA)
Time frame: up to Week 60
Average change in BCVA from Baseline up to a period from Week 48 to Week 60
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: from Week 48 to Week 60
Occurrence of BCVA improvement of ≥ 10 and ≥ 15 letters from Baseline at a period from Week 48 to Week 60
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Baseline, and from Week 48 to Week 60
Occurrence of BCVA ≥ 69 letters at a period from Week 48 to Week 60
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: from Week 48 to Week 60
Average change in BCVA from Baseline up to a period from Week 48 to Week 60 categorized into 2 groups, lower half of Baseline BCVA and upper half of Baseline BCVA
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
Time frame: Baseline, and from Week 48 to Week 60
Number of participants with complete polypoidal lesion regression at Week 12 and at a period from Week 48 to Week 60
Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA). Polypoidal regression is defined as: Complete polypoidal regression: complete disappearance of any hyper-cyanescent polypoidal lesion previously identified at Baseline Partial polypoidal regression is defined as either partial regression in number (i.e., fewer hyper-cyanescent lesions) compared with Baseline or in size (i.e., smaller hyper-cyanescent lesion) compared with Baseline
Time frame: at Week 12, and from Week 48 to Week 60
Number of participants with inactive polypoidal lesions at Week 12 and at a period from Week 48 to Week 60
Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA). Inactive polypoidal lesion is defined as the Absence of polypoidal lesions on ICGA or in case polypoidal lesions were identified or the Absence of new or persistent fluid on OCT or the Absence of leakage on angiography
Time frame: at Week 12, and from Week 48 to Week 60
Change in number and area of polypoidal lesions from Baseline at Week 12 and at a period from Week 48 to Week 60
Polypoidal lesion and Branching vascular network (BVN) evaluation by Indocyanine Green Angiography (ICGA).
Time frame: Baseline, Week 12, and from Week 48 to Week 60
Average change from Baseline in central subfield thickness (CSFT) up to Week 60
Change in CSFT from baseline up to week 60 will be analyzed by fitting mixed model repeated measures (MMRM) with observed data including treatment, visit, baseline central subfield thickness (CSFT) categories, age categories and treatment by visit interaction as factors.
Time frame: up to Week 60
Average change from Baseline in maximum thickness of intraretinal fluid (IRF) up to Week 60
Change in maximum thickness of IRF from baseline up to week 60 will be analyzed by fitting mixed model repeated measures (MMRM) with observed data including treatment, visit, baseline central subfield thickness (CSFT) categories, age categories and treatment by visit interaction as factors.
Time frame: up to Week 60
Average change from Baseline in maximum thickness of subretinal fluid (SRF) up to Week 60
Change in maximum thickness of SRF from baseline up to week 60 will be analyzed by fitting mixed model repeated measures (MMRM) with observed data including treatment, visit, baseline central subfield thickness (CSFT) categories, age categories and treatment by visit interaction as factors.
Time frame: up to Week 60
Average change from Baseline in maximum thickness of sub-retinal pigment epithelium (sub-RPE) fluid up to Week 60
Change in maximum thickness of sub-RPE fluid from baseline up to week 60 will be analyzed by fitting mixed model repeated measures (MMRM) with observed data including treatment, visit, baseline central subfield thickness (CSFT) categories, age categories and treatment by visit interaction as factors.
Time frame: up to Week 60
Average change from Baseline in maximum thickness of pigment epithelial detachment (PED) up to Week 60
Change in maximum PED thickness from baseline up to week 60 will be analyzed by fitting mixed model repeated measures (MMRM) with observed data including treatment, visit, baseline central subfield thickness (CSFT) categories, age categories and treatment by visit interaction as factors.
Time frame: up to Week 60
Number of participants with intraretinal fluid (IRF) and/or subretinal fluid (SRF) and/or sub-retinal pigment epithelium (sub-RPE) fluid up to Week 60
As analyzed by fitting mixed model repeated measures (MMRM) with observed data including treatment, visit, baseline central subfield thickness (CSFT) categories, age categories and treatment by visit interaction as factors.
Time frame: up to Week 60
Incidence of ocular adverse events (AEs) up to Week 60
An ocular AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant regarding the eye.
Time frame: Up to Week 60
Incidence of non-ocular adverse events (AEs) up to Week 60
An AE is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant.
Time frame: Up to Week 60
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Access criteria: This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Data sharing details ↗ · www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brolucizumab
Polypoidal Choroidal Vasculopathy →