Macular Polypoidal Choroidal Vasculopathy (PCV)Phase 3PROUDNCT05666804
Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy
A Phase 3 study testing Brolucizumab 6mg in people with Macular Polypoidal Choroidal Vasculopathy (PCV), run by Novartis Pharmaceuticals at 15 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Macular Polypoidal Choroidal Vasculopathy (PCV)
- What is being tested?
- Brolucizumab 6mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 6 Feb 2023to 10 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Participants ≥ 50 years of age at Screening.
- Study eye:
- Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color fundus photography (CFP), Fluorescein angiography (FA) and spectral domain optical coherence tomography (SD-OCT) AND presence of Intraretinal fluid (IRF) or Subretinal fluid (SRF) that affects the central subfield as seen by SD-OCT.
- Best-corrected visual acuity (BCVA) score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline.
- Greatest liner dimension (GLD) of the total lesion area (branching vascular network [BVN] + polypoidal lesion) < 5400 μm (equivalent to 9 macular photocoagulation study [MPS] Disc Area) as delineated by Indocyanin green angiography (ICGA).
Who cannot join
- Ocular conditions:
- Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period.
- Any active intraocular or periocular infection or active intraocular inflammation (IOI) (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye or fellow eye at Screening or Baseline.
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to Investigator's judgment, at Screening or Baseline.
- Any Polypoidal choroidal vasculopathy (PCV) masquerades like macular aneurysms, macular telangiectasia, etc. in study eye.
- 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.
Show all 13Show fewer
- Ocular treatments in the study eye:
- Previous treatment with any anti-Vascular endothelial growth factor (VEGF) drugs or investigational drugs at any time prior to Baseline.
- Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.
- 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:
- Stroke or myocardial infarction during the 6-month period prior to Baseline.
- Systemic anti-VEGF therapy any time prior to Baseline.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Busan, 48108
Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Busan, 613-815
Novartis Investigative Site
Daegu, Dalseo Gu, 42602
Novartis Investigative Site
Daegu, 705703
Novartis Investigative Site
Daejeon, Korea, 35015
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Seoul, Korea, 02447
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, 01000
Novartis Investigative Site
Seoul, 01869
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06273
About this study
Official title: A 60-week, Phase IIIb, Randomized, Multi-center Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PROUD Study)
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.
Read the detailed description
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).
- The study duration will be up to 60 weeks.
- The treatment duration will be up to 56 weeks.
- The visit frequency is not fixed and may be reduced or extended depending on whether disease activity is controlled.
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.
- Being tested
- Brolucizumab 6mg
- Keywords
- Neovascular age-related macular degeneration, polypoidal choroidal vasculopathy, anti-vascular endothelial growth factor, brolucizumab, personalized regimen, treat-and-extend, Retina damage, Retinal disease, Vascular disease, Eye disease, blind spot, fluid leak into or under the retina, blood leak into or under the retina, macular polypoidal choroidal vasculopathy (PCV), PCV
- Medical subject headings
- Polypoidal Choroidal Vasculopathy, Retinal Diseases, Vascular Diseases, Eye Diseases, Scotoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brolucizumab 6mgDrug
Also called Beovu
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
Brolucizumab 6mgDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Personalized regimen arm | Experimental | 1~3 x 4-week loading injections and one 8-week injection, followed by Treat-and-extend (T\&E) regimen up to Week 56 Receives: Drug: Brolucizumab 6mg |
| Standard regimen arm | Active comparator | 3 x 4-week loading injections and disease activity assessment at week 16 followed by q12w/q8w up to Week 56 Receives: Drug: Brolucizumab 6mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from Week 48 to Week 60
Secondary outcomes (21)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start6 Feb 2023
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Polypoidal Choroidal Vasculopathy (PCV)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666804
- Sponsor's protocol ID
- CRTH258AKR03
- Acronym
- PROUD
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 60-week, Phase IIIb, Randomized, Multi-center Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PROUD Study)
- ClinicalTrials.gov ID
- NCT05666804
- Acronym / sponsor ID
- PROUD / CRTH258AKR03
- Keywords
- Neovascular age-related macular degeneration, polypoidal choroidal vasculopathy, anti-vascular endothelial growth factor, brolucizumab, personalized regimen, treat-and-extend, Retina damage, Retinal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
- The study duration will be up to 60 weeks.
- The treatment duration will be up to 56 weeks.
- The visit frequency is not fixed and may be reduced or extended depending on whether disease activity is controlled.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized regimen arm | Experimental | Drug: Brolucizumab 6mg1~3 x 4-week loading injections and one 8-week injection, followed by Treat-and-extend (T\&E) regimen up to Week 56 |
| Standard regimen arm | Active comparator | Drug: Brolucizumab 6mg3 x 4-week loading injections and disease activity assessment at week 16 followed by q12w/q8w up to Week 56 |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Participants ≥ 50 years of age at Screening.
- Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color fundus photography (CFP), Fluorescein angiography (FA) and spectral domain optical coherence tomography (SD-OCT) AND presence of Intraretinal fluid (IRF) or Subretinal fluid (SRF) that affects the central subfield as seen by SD-OCT.
- Best-corrected visual acuity (BCVA) score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline.
- Greatest liner dimension (GLD) of the total lesion area (branching vascular network [BVN] + polypoidal lesion) < 5400 μm (equivalent to 9 macular photocoagulation study [MPS] Disc Area) as delineated by Indocyanin green angiography (ICGA).
Key exclusion criteria (13 listed)
- Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period.
- Any active intraocular or periocular infection or active intraocular inflammation (IOI) (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye or fellow eye at Screening or Baseline.
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to Investigator's judgment, at Screening or Baseline.
- Any Polypoidal choroidal vasculopathy (PCV) masquerades like macular aneurysms, macular telangiectasia, etc. in study eye.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brolucizumab 6mgAlso: BeovuBrolucizumab 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 | Drug | Personalized regimen arm |
| Brolucizumab 6mgAlso: BeovuBrolucizumab 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 | Drug | Standard regimen arm |
Primary outcome
Average change in Best Corrected Visual Acuity (BCVA) from Baseline at a period from Week 48 to Week 60
Time frame: from Week 48 to Week 60
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts
21 secondary outcomes
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
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
Time frame: up to Week 60
Distribution of the maximal intervals with no disease activity up to Week 60
Time frame: up to Week 60
Distribution of the last interval at a period from Week 48 to Week 60
Time frame: from Week 48 to Week 60
Time from the last loading injection to the first visit with no disease activity
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
Time frame: up to Week 60
Average change in BCVA from Baseline up to a period from Week 48 to Week 60
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
Time frame: Baseline, and from Week 48 to Week 60
Occurrence of BCVA ≥ 69 letters at a period from Week 48 to Week 60
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
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
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
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
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
Time frame: up to Week 60
Average change from Baseline in maximum thickness of intraretinal fluid (IRF) up to Week 60
Time frame: up to Week 60
Average change from Baseline in maximum thickness of subretinal fluid (SRF) up to Week 60
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
Time frame: up to Week 60
Average change from Baseline in maximum thickness of pigment epithelial detachment (PED) up to Week 60
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
Time frame: up to Week 60
Incidence of ocular adverse events (AEs) up to Week 60
Time frame: Up to Week 60
Incidence of non-ocular adverse events (AEs) up to Week 60
Time frame: Up to Week 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brolucizumab 6mg in people with Macular Polypoidal Choroidal Vasculopathy (PCV), run by Novartis Pharmaceuticals at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in Best Corrected Visual Acuity (BCVA) from Baseline at a period from Week 48 to Week 60 (time frame: from Week 48 to Week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.