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

Neovascular Age-related Macular Degeneration Clinical Trial

— BESRA  

Official title:

Brolucizumab Treatment Experience Study of Patients With Neovascular Age-related Macular Degeneration (nAMD) in UK Routine Clinical Practice (BESRA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05112835
• Other study ID #: CRTH258AGB02
• Status: Terminated
• Start date: November 19, 2021
• Est. completion date: September 8, 2022

Study information

• Verified date: February 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 302
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Other:
• brolucizumab
There is no treatment allocation. The decision to administer brolucizumab is made by the treating physician independent of the study, prior to the inclusion of the patient into the study

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Abergele	Conwy
United Kingdom	Novartis Investigative Site	Barnsley
United Kingdom	Novartis Investigative Site	Bedford
United Kingdom	Novartis Investigative Site	Blackburn	Lancashire
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Coventry
United Kingdom	Novartis Investigative Site	Frimley	Surrey
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Hull
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Macclesfield
United Kingdom	Novartis Investigative Site	Oxford
United Kingdom	Novartis Investigative Site	Peterborough	Cambridgeshire
United Kingdom	Novartis Investigative Site	Sunderland
United Kingdom	Novartis Investigative Site	Uxbridge	London
United Kingdom	Novartis Investigative Site	Warwick

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) of patients with absence of retinal fluid	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)	Month 12
Secondary	Percentage (%) of patients with absence of SRF	Percentage (%) of patients without sub-retinal fluid (SRF) to be collected (fluid free)	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	Percentage (%) of patients with absence of IRF	Percentage (%) of patients without intra-retinal fluid (IRF) to be collected (fluid-free)	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	Percentage (%) of patients with absence of sub-RPE fluid	Percentage (%) of patients without sub-Retinal Pigment Epithelium fluid (sub-RPE) to be collected (fluid-free)	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	Percentage (%) of patients with absence of PED	Percentage (%) of patients without retinal pigment epithelial detachment (PED) to be collected	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	Percentage (%) of patients with absence of retinal fluid	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	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	CRT change from baseline	measurement of Central Retinal Thickness (CRT) from baseline to be collected	Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	CST change from baseline	Measurement of Central Subfield Thickness (CST) from baseline to be collected	Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	BCVA change from baseline	Change in Best Corrected Visual Acuity (BCVA) from baseline to be corrected	Baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	Percentage (%) of patients with BCVA =70 ETDRS letters	Percentage of patients with Best Corrected Visual Acuity (BCVA) =70 ETDRS letters to be collected	Month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Secondary	Total number of injections received	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	Up to 60 months
Secondary	Duration of injection intervals per patient	Duration of (all) injection intervals per patient during Months 0-6, 0-12, 13-24, 25-36, 37-48 and 49-60	Up to 60 months
Secondary	Percentage (%) of patients with =3 brolucizumab injections	Percentage of patients completing the loading phase to be collected	Month 3
Secondary	Percentage (%) of patients who switch from brolucizumab to another anti-VEGF	Percentage of patients who switch from brolucizumab to another anti-VEGF to be collected	Month 12, month 24, month 36, month 48 and month 60
Secondary	Percentage (%) of patients that discontinue Brolucizumab therapy	Percentage of patients that discontinue therapy to be collected	Up to 60 months
Secondary	Percentage (%) of patients with IOI including RV and RVO	Percentage of patients with Intraocular Inflammation (IOI) including Retinal vasculitis (RV) and Retinal vascular occlusion (RVO) to be collected	Up to 60 months
Secondary	Percentage (%) of patients with disease control	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	Month 12 and month 24
Secondary	Change in macular volume of IRF/SRF by central reading center	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.	Baseline at Month 12