Brolucizumab Treatment Experience Study of Patients With nAMD in UK Routine Clinical Practice

Terminated

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Other: brolucizumab

• Registration Number: NCT05112835
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

BESRA is a national, multi-center, prospective, observational study to assess the effectiveness of brolucizumab intravitreal injections in patients with nAMD treated in the UK.

Detailed Description

Data will be collected in a standardized manner from hospital medical records (paper and electronic) at participating centers for up to 60 months post- initiation of brolucizumab. In addition to the collection of data from medical records, retinal OCT images collected during the first two years of treatment will be transferred to a central reading center for independent grading and interpretation, in order to support the validity of anatomical measurements relevant to the primary and secondary study objectives.

Patients will be treated with brolucizumab according to routine clinical practice, independent of the study setting.

Key study design definitions:

* Index date: the date of the first brolucizumab injection.

* Index eye: the first eye to be injected with brolucizumab (analyses will be conducted for the index eye only, unless otherwise stated).

* Post-index period: time between index date and the earliest of treatment discontinuation, date of death or the date of the last recorded visit within the 60 months post-index (2-month window).

* Study period: The period between 01 September 2020 and 01 March 2027, to allow 6 months pre-index period and up to 60 months (±2 months window) follow-up for each enrolled patient.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Study Start: 2021-11-19
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-27
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

1. Diagnosis of nAMD
2. ≥50 years of age at index date
3. Receipt of at least one injection of brolucizumab during the eligibility period
4. Able and willing to provide signed informed consent

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Exclusion Criteria

1. Received treatment for retinal vein occlusion, diabetic macular edema (DME) and/or myopic choroidal neovascularization (mCNV), and/or has received a new diagnosis of diabetes-related macular degeneration in the index eye within 6 months prior to the index date
2. Receipt of anti-VEGF treatment other than brolucizumab in the index eye at index date
3. Any active intraocular or periocular infection or active intraocular inflammation in the index eye at index date
4. Has been on anti-VEGF treatment for longer than 3 years (before index date)
5. Has a contraindication and is not eligible for treatment with brolucizumab according to the Beovu® (brolucizumab) Summary of Product Characteristics (SmPC) ("Beovu 120 mg/ml solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)" 2020)
6. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from participating in the study
7. Participating in a parallel interventional clinical study
8. Participating in a parallel non-interventional study (NIS) generating primary data for an anti- VEGF drug.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
brolucizumab	brolucizumab	brolucizumab intravitreal injections in patients with nAMD treated in the UK

Primary Outcome Measures

Name	Time	Method
Percentage (%) of patients with absence of retinal fluid	Month 12	Percentage (%) of patients with absence of retinal fluid (no Sub-retinal Fluid (SRF) and no Intra-retinal fluid (IRF) as documented in medical records by the treating physician in relation to OCT results)

Secondary Outcome Measures

Name	Time	Method
Percentage (%) of patients that discontinue Brolucizumab therapy	Up to 60 months	Percentage of patients that discontinue therapy to be collected
Percentage (%) of patients with absence of IRF	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Percentage (%) of patients without intra-retinal fluid (IRF) to be collected (fluid-free)
Percentage (%) of patients with absence of retinal fluid	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Percentage (%) of patients without intra-retinal fluid (IRF), Sub-retinal Fluid (SRF) and sub-Retinal pigment epithelium (sub-RPE) fluid (fluid free) to be collected
CRT change from baseline	Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60	measurement of Central Retinal Thickness (CRT) from baseline to be collected
CST change from baseline	Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Measurement of Central Subfield Thickness (CST) from baseline to be collected
Percentage (%) of patients with absence of PED	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Percentage (%) of patients without retinal pigment epithelial detachment (PED) to be collected
Percentage (%) of patients with IOI including RV and RVO	Up to 60 months	Percentage of patients with Intraocular Inflammation (IOI) including Retinal vasculitis (RV) and Retinal vascular occlusion (RVO) to be collected
Percentage (%) of patients with absence of SRF	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Percentage (%) of patients without sub-retinal fluid (SRF) to be collected (fluid free)
Percentage (%) of patients with absence of sub-RPE fluid	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Percentage (%) of patients without sub-Retinal Pigment Epithelium fluid (sub-RPE) to be collected (fluid-free)
BCVA change from baseline	Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Change in Best Corrected Visual Acuity (BCVA) from baseline to be corrected
Percentage (%) of patients with BCVA ≥70 ETDRS letters	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60	Percentage of patients with Best Corrected Visual Acuity (BCVA) ≥70 ETDRS letters to be collected
Percentage (%) of patients with ≥3 brolucizumab injections	Month 3	Percentage of patients completing the loading phase to be collected
Duration of injection intervals per patient	Up to 60 months	Duration of (all) injection intervals per patient during Months 0-6, 0-12, 13-24, 25-36, 37-48 and 49-60
Total number of injections received	Up to 60 months	Total number of injections received between Months 0 (index)-3, 4-6, 7-12, 0-12, 13-24, 25-36, 37-48, and 49-60
Percentage (%) of patients who switch from brolucizumab to another anti-VEGF	Month 12, month 24, month 36, month 48 and month 60	Percentage of patients who switch from brolucizumab to another anti-VEGF to be collected
Percentage (%) of patients with disease control	Month 12 and month 24	Percentage of patients with disease control, defined as absence of Intra-retinal fluid (IRF) and Sub-retinal Fluid (SRF), by the central reading center to be collected
Change in macular volume of IRF/SRF by central reading center	Baseline at Month 12	Change in macular volume of IRF/SRF by central reading center according to type of fluid available at baseline. Macular volume will be quantified using a specialized validated AI algorithm.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Warwick, United Kingdom