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Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal (BLUESKY-PT)

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ClinicalTrials.gov Identifier: NCT04764656
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.

Condition or disease Intervention/treatment
Neovascular Age-related Macular Degeneration (nAMD) Drug: Brolucizumab

Detailed Description:

Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. 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 follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.

Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Brolucizumab
Naïve (Patients being the first time treated) and pre-treated patients
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye [ Time Frame: month 12 ]
    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).


Secondary Outcome Measures :
  1. Fluid resolution after initiation of brolucizumab [ Time Frame: month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  2. Visual Actuity (VA) change from baseline [ Time Frame: Baseline, month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  3. Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity [ Time Frame: month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  4. Number of injections and total number of visits [ Time Frame: month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  5. Describe the distribution of injection intervals [ Time Frame: month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  6. 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

  7. 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

  8. Discontinuation rate [ Time Frame: month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  9. Assess the safety of brolucizumab [ Time Frame: month 24 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   40 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include an estimated number of 120 naïve patients and 180 switch patients with a diagnosis of nAMD being treated with brolucizumab in private clinics in Portugal during the recruitment period
Criteria

Inclusion Criteria:

  1. Diagnosis of nAMD
  2. Male and Female patients with ≥40 years of age at index
  3. Receipt of at least one injection of brolucizumab during the recruitment period
  4. Signed written informed consent

Exclusion Criteria:

  1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
  2. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
  3. 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
  4. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
  5. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
  6. Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
  7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
  8. Patients participating in parallel in an interventional clinical trial
  9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
  10. Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
  11. Subretinal blood affecting the foveal center point and/or >50% of the lesion of the study eye at Screening
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04764656


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Portugal
Novartis Investigative Site Recruiting
Funchal, Portugal, 00-024
Novartis Investigative Site Recruiting
Leiria, Portugal, 2410-187
Novartis Investigative Site Recruiting
Lisboa, Portugal, 1050-078
Novartis Investigative Site Withdrawn
Lisboa, Portugal, 1050-085
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1200-473
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1500-473
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1600-209
Novartis Investigative Site Active, not recruiting
Lisboa, Portugal, 1649-020
Novartis Investigative Site Recruiting
Lisboa, Portugal, 1990-196
Novartis Investigative Site Active, not recruiting
Porto, Portugal, 4050-115
Novartis Investigative Site Active, not recruiting
Santa Maria da Feira, Portugal, 4520 211
Novartis Investigative Site Recruiting
Tomar, Portugal, 2300-625
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04764656    
Other Study ID Numbers: CRTH258APT02
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Beovu
Brolucizumab
nAMD
non-interventional trial
fluid resolution
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases