Study of brolucizumab in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneration

A one-year, single-arm, open-label, multicenter study assessing the effect of brolucizumab on disease control in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneration (SWIFT) - SWIFT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004145-33-FR

Enrollment

362

Registered

2019-12-18

Start date

2020-04-07

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neovascular age-related macular degeneration MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: RTH258 Product Code: RTH258 formerly ESBA1008 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: BROLUCIZUMAB CAS Number: 1531589-13-5 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients must provide written informed consent before any study-related procedures are performed. • Patients must be 50 years of age or older at Screening/Baseline. Study eye: • Active CNV lesions secondary to nAMD diagnosed =65 years) yes F.1.3.1 Number of subjects for this age range 277

Exclusion criteria

Exclusion criteria: • Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Screening/Baseline. • Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA 25 mmHg on medication or according to Investigator’s judgment. • Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline. Systemic conditions or treatments • Stroke or myocardial infarction in the 6-month period prior to Screening/Baseline. • Systemic anti-VEGF therapy at any time. Other • Women of childbearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of brolucizumab 6 mg on disease control ;Secondary Objective: • To evaluate the long term effects of brolucizumab 6 mg on disease control • To evaluate the effect of brolucizumab 6 mg on anatomical parameters • To evaluate the durability of brolucizumab 6 mg • To evaluate functional outcomes • To assess the safety and tolerability of brolucizumab 6 mg;Primary end point(s): Proportion of patients with no disease activity at Week 16;Timepoint(s) of evaluation of this end point: at Week 16	—

Measure

Time frame

Main Objective: To evaluate the effect of brolucizumab 6 mg on disease control ;Secondary Objective: • To evaluate the long term effects of brolucizumab 6 mg on disease control • To evaluate the effect of brolucizumab 6 mg on anatomical parameters • To evaluate the durability of brolucizumab 6 mg • To evaluate functional outcomes • To assess the safety and tolerability of brolucizumab 6 mg;Primary end point(s): Proportion of patients with no disease activity at Week 16;Timepoint(s) of evaluation of this end point: at Week 16

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of patients with no disease activity at Week 48 • Change from Baseline in CFST as assessed by OCT over time up to Week 48 • Absence of IRF, SRF, and sub-RPE fluid as assessed by OCT over time up to Week 48 • Proportion of patients with a dry retina (neither IRF nor SRF) up to Week 48 • Distribution of the last interval with no disease activity up to Week 48 • Distribution of the maximal intervals with no disease activity up to Week 48 • Average change in BCVA from Baseline up to Week 48 • Incidence of AEs (serious and non-serious) up to Week 48;Timepoint(s) of evaluation of this end point: • at Week 48 • from Baseline over time up to Week 48 • over time up to Week 48 • up to Week 48 • up to Week 48 • up to Week 48 • from Baseline up to Week 48 • up to Week 48	—

Measure

Time frame

Secondary end point(s): • Proportion of patients with no disease activity at Week 48 • Change from Baseline in CFST as assessed by OCT over time up to Week 48 • Absence of IRF, SRF, and sub-RPE fluid as assessed by OCT over time up to Week 48 • Proportion of patients with a dry retina (neither IRF nor SRF) up to Week 48 • Distribution of the last interval with no disease activity up to Week 48 • Distribution of the maximal intervals with no disease activity up to Week 48 • Average change in BCVA from Baseline up to Week 48 • Incidence of AEs (serious and non-serious) up to Week 48;Timepoint(s) of evaluation of this end point: • at Week 48 • from Baseline over time up to Week 48 • over time up to Week 48 • up to Week 48 • up to Week 48 • up to Week 48 • from Baseline up to Week 48 • up to Week 48

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Countries

France

Contacts

Public ContactInformation&Communication Médicales

Novartis Pharma S.A.S

icm.phfr@novartis.com0033155476600

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026