Neovascular Age-related Macular Degeneration (nAMD)BLUESKY-PTNCT04764656
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal
An observational study of Neovascular Age-related Macular Degeneration (nAMD), run by Novartis Pharmaceuticals at 11 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 110 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration (nAMD)
- What is being tested?
- Brolucizumab
- How many people
- 81 participants
- Where
- 11 sitesPortugal
- Study dates
- 10 May 2021to 16 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Diagnosis of nAMD
- Male and Female patients with ≥40 years of age at index
- Receipt of at least one injection of brolucizumab during the recruitment period
- Signed written informed consent
Who cannot join
- Patients treated for RVO, DME, mCNV, and 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)
- Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
Show all 11Show fewer
- 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
- 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
- Subretinal blood affecting the foveal center point and/or >50% of the lesion of the study eye at Screening
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Portugal11 sites
Novartis Investigative Site
Funchal, 00-024
Novartis Investigative Site
Leiria, 2410-187
Novartis Investigative Site
Lisbon, 1050-078
Novartis Investigative Site
Lisbon, 1200-473
Novartis Investigative Site
Lisbon, 1500-473
Novartis Investigative Site
Lisbon, 1600-209
Novartis Investigative Site
Lisbon, 1649-020
Novartis Investigative Site
Lisbon, 1990-196
Novartis Investigative Site
Porto, 4050-115
Novartis Investigative Site
Santa Maria da Feira, 4520 211
Novartis Investigative Site
Tomar, 2300-625
About this study
Official title: Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
Read the 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.
- Being tested
- Brolucizumab
- Keywords
- Beovu, Brolucizumab, nAMD, non-interventional trial, fluid resolution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrolucizumabDrug
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Brolucizumab | Naïve (Patients being the first time treated) and pre-treated patients Receives: Drug: Brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye
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).
Measured: month 12
Secondary outcomes (9)
Fluid resolution after initiation of brolucizumab
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Visual Actuity (VA) change from baseline
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: Baseline, month 24
Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Number of injections and total number of visits
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Describe the distribution of injection intervals
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF)
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Discontinuation rate
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Assess the safety of brolucizumab
Detailed Outcome Measure will be defined in the Statistical Analysis Plan
Measured: month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 May 2021
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Why it stopped: The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764656
- Sponsor's protocol ID
- CRTH258APT02
- Acronym
- BLUESKY-PT
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal
- ClinicalTrials.gov ID
- NCT04764656
- Acronym / sponsor ID
- BLUESKY-PT / CRTH258APT02
- Keywords
- Beovu, Brolucizumab, nAMD, non-interventional trial, fluid resolution
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brolucizumab | – | Drug: BrolucizumabNaïve (Patients being the first time treated) and pre-treated patients |
Who may qualify
- Ages
- 40 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Diagnosis of nAMD
- Male and Female patients with ≥40 years of age at index
- Receipt of at least one injection of brolucizumab during the recruitment period
- Signed written informed consent
Key exclusion criteria (11 listed)
- Patients treated for RVO, DME, mCNV, and 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrolucizumabThere is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled. | Drug | Brolucizumab |
Primary outcome
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).
9 secondary outcomes
Fluid resolution after initiation of brolucizumab
Time frame: month 24
Visual Actuity (VA) change from baseline
Time frame: Baseline, month 24
Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity
Time frame: month 24
Number of injections and total number of visits
Time frame: month 24
Describe the distribution of injection intervals
Time frame: month 24
Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done
Time frame: month 24
Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF)
Time frame: month 24
Discontinuation rate
Time frame: month 24
Assess the safety of brolucizumab
Time frame: month 24
Results and safety
The study was stopped early (reason given: The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Results for CRTH258APT02 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration (nAMD), run by Novartis Pharmaceuticals at 11 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.