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

NCT05666804 | Completed Phase 3

• 1 other identifier: CRTH258AKR03
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 15

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.

Conditions

Macular Polypoidal Choroidal Vasculopathy (PCV)

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

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Week 12, Week 16, and from Week 48 to Week 60

• Distribution of last completed treatment interval with no disease activity up to Week60

  up to Week 60

• Distribution of the maximal intervals with no disease activity up to Week 60

  up to Week 60

• Distribution of the last interval at a period from Week 48 to Week 60

  from Week 48 to Week 60

• Time from the last loading injection to the first visit with no disease activity

  Up to Week 60

Study Arms (2)

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

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

Drug: Brolucizumab 6mg

Interventions

Brolucizumab 6mg 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

Also known as: Beovu

Personalized regimen arm

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

Novartis Investigative Site

Daegu, Dalseo Gu, 42602, South Korea

Location

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, 13620, South Korea

Location

Novartis Investigative Site

Daejeon, Korea, 35015, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 02447, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 03080, South Korea

Location

Novartis Investigative Site

Busan, 48108, South Korea

Location

Novartis Investigative Site

Busan, 49241, South Korea

Location

Novartis Investigative Site

Busan, 613-815, South Korea

Location

Novartis Investigative Site

Daegu, 705703, South Korea

Location

Novartis Investigative Site

Gwangju, 61469, South Korea

Location

Novartis Investigative Site

Seoul, 01000, South Korea

Location

Novartis Investigative Site

Seoul, 01869, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy; Retinal Diseases; Vascular Diseases; Eye Diseases; Scotoma

Interventions

brolucizumab

Condition Hierarchy (Ancestors)

Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: February 6, 2023
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Access Criteria: This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Locations

KR (15)