Observational Study to Evaluate Fluid Resolution and Effectiveness in Patients Receiving Beovu in Neovascular Age-related Macular Degeneration (BLUE SKY)
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| ClinicalTrials.gov Identifier: NCT04543331 |
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Recruitment Status :
Recruiting
First Posted : September 10, 2020
Last Update Posted : September 19, 2022
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This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in nAMD patients being treated for nAMD with brolucizumab according to the SmPC.
An observational study design, without a strict, mandated visit schedule or mandated treatment regimen was chosen as the most appropriate to collect available data in a real life setting. For that reason, this NIS does not impose a therapy protocol, diagnostic/therapeutic procedure or a visit schedule. The diagnostic or monitoring procedures are only those ordinarily applied to the therapeutic strategy and to routine clinical care and will take place as per investigator's discretion. This includes e.g. visit frequency, injection frequency and types of assessments performed - only data from routine medical practice will be collected as part of the study.
| Condition or disease | Intervention/treatment |
|---|---|
| Neovascular Age-related Macular Degeneration (nAMD) | Drug: brolucizumab |
BLUE SKY consists of the two main study modules DEEP BLUE (Observational stuDy to Evaluate fluid resolution and Effectiveness in Patients receiving Beovu (broLUcizumab) in neovascular age-related macular dEgeneration) and BIRL (Brolucizumab In Real Life).
Patients will be enrolled at approximately 32 centers, which will be representatively distributed amongst the 16 German federal states. This will ensure to reflect all state-specific health insurance laws and guidelines. Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given. Out of the patients, 1/3 should be pre-treated and 2/3 naïve. All patients will be documented for the DEEP BLUE study module (Full Analysis Set).
For the BIRL module, only naïve patients enrolled in 7 selected centers will be documented. All these centers are equipped with the Zeiss PlexElite OCT-A, needed to assess and analyze BIRL specific objectives in a comparable setting. Only images from routine medical practice will be collected as part of the study.
The study eye will be defined as the first eye treated during the study, the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion).
The prospective observation period per patient will be up to 24 months.
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | OBservationaL stUdy to Evaluate Fluid reSolution and Effectiveness in Patients Receiving Beovu (Brolucizumab) Under KeY Treatment Schemes in Neovascular Age-related Macular Degeneration |
| Actual Study Start Date : | November 5, 2020 |
| Estimated Primary Completion Date : | November 7, 2024 |
| Estimated Study Completion Date : | November 7, 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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treatment naïve patients
Patients being the first time treated for nAMD
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Drug: brolucizumab
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled. |
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pre-treated patients
Patients already being treated for nAMD
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Drug: brolucizumab
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled. |
- Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye. [ Time Frame: month 12 ]This Oucome Measure is part of the Deep Blue module. This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes included in the study, analyzed as two independent groups (naïve and switch).
- Mean change in visual actuity (VA) in the study eye considering treatment naïve subgroup [ Time Frame: Baseline, month 12 ]
Mean change in visual actuity (VA) under clinic specific routine treatment schemes Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eyes.
BIRL module
- Morphological CNV-Changes in the study eye considering treatment naïve subgroup [ Time Frame: Baseline, month 12 ]
Morphological Choroidal Neovascularization (CNV)-Changes under clinic specific routine treatment schemes Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in patient eyes.
BIRL module
- Fluid resolution after initiation of brolucizumab [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Visual Actuity (VA) change from baseline [ Time Frame: Baseline, month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Number of injections and total number of visits [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Describe the distribution of injection intervals [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF) [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Discontinuation rate [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
- Assess the safety of brolucizumab [ Time Frame: month 24 ]Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 199 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
The unit of analysis is patient-eye, i.e. all criteria should be applied to the study eye, unless otherwise specified. Patients will be included in the study if they fulfil the following requisites:
- Diagnosis of nAMD
- Male and Female patients with ≥40 years of age at index
- Decision to treatment with brolucizumab at baseline visit
- Signed written informed consent
- Patients for whom a therapy with brolucizumab is medically indicated
- Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at Screening
Exclusion Criteria:
- Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
- Patients treated for RVO, DME, mCNV, or have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
- Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
- Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at Screening
- Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
- Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
- Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
- Patients participating in parallel in an interventional clinical trial
- Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543331
| Contact: Novartis Pharmaceuticals | +41613241111 | novartis.email@novartis.com | |
| Contact: Novartis Pharmaceuticals |
Show 49 study locations
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT04543331 |
| Other Study ID Numbers: |
CRTH258ADE02 |
| First Posted: | September 10, 2020 Key Record Dates |
| Last Update Posted: | September 19, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Beovu Brolucizumab nAMD |
non-interventional trial effectiveness fluid resolution |
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Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |