Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy

NCT ID: NCT05666804

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-06
• Study Completion Date: 2025-09-10

Brief 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.

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.

Conditions

Macular Polypoidal Choroidal Vasculopathy (PCV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Brolucizumab 6mg

Intervention Type: DRUG

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

Standard regimen arm

3 x 4-week loading injections and disease activity assessment at week 16 followed by q12w/q8w up to Week 56

Group Type: ACTIVE_COMPARATOR

Brolucizumab 6mg

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Brolucizumab 6mg

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

Intervention Type: DRUG

Other Intervention Names

Beovu; Beovu

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study.

2. Participants ≥ 50 years of age at Screening.

Study eye:

3. 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.

4. 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.

5. 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).

Exclusion Criteria

Ocular conditions:

1. 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.

2. 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.

3. 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.

4. Any Polypoidal choroidal vasculopathy (PCV) masquerades like macular aneurysms, macular telangiectasia, etc. in study eye.

5. 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:

6. Previous treatment with any anti-Vascular endothelial growth factor (VEGF) drugs or investigational drugs at any time prior to Baseline.

7. Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.

8. 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:

9. Stroke or myocardial infarction during the 6-month period prior to Baseline.

10. Systemic anti-VEGF therapy any time prior to Baseline.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Daegu, Dalseo Gu, South Korea

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Daejeon, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Busan, , South Korea

Novartis Investigative Site

Busan, , South Korea

Novartis Investigative Site

Busan, , South Korea

Novartis Investigative Site

Daegu, , South Korea

Novartis Investigative Site

Gwangju, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CRTH258AKR03

Identifier Type: -

Identifier Source: org_study_id