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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05112835
Other study ID # CRTH258AGB02
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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