Neovascular (Wet) Age-related Macular DegenerationNCT06184360
Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
An observational study of Neovascular (Wet) Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular (Wet) Age-related Macular Degeneration
- How many people
- 2,079 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 16 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- At least 18 years old at the time of their first (index) injection of brolucizumab.
- Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.
- Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.
Who cannot join
- Had received any other anti-VEGF agent between the index injection and 12-month follow-up.
- Lacked information about the laterality of disease at the time of the index injection.
- Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment-Experienced | Not described | |
| Treatment-Naive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status
Measured: Baseline up to 12 months
Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment
Measured: Baseline up to 12 months
Number of eyes with adverse events
Measured: Baseline up to 12 months
Time to adverse event
Measured: Baseline up to 12 months
Number of brolucizumab injections prior to adverse event
Measured: Baseline up to 12 months
Secondary outcomes (1)
Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start31 May 2022
- Primary completion30 Jun 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) Age-related Macular DegenerationStudies 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
- Retrospective
- Enrolment
- 2,079 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
- NCT06184360
- Sponsor's protocol ID
- CRTH258A2014
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT06184360
- Acronym / sponsor ID
- CRTH258A2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,079 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 28 Dec 2023 (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 was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-Experienced | – | – |
| Treatment-Naive | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (3 listed)
- At least 18 years old at the time of their first (index) injection of brolucizumab.
- Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.
- Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.
Key exclusion criteria (3 listed)
- Had received any other anti-VEGF agent between the index injection and 12-month follow-up.
- Lacked information about the laterality of disease at the time of the index injection.
- Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status
Time frame: Baseline up to 12 months
Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment
Time frame: Baseline up to 12 months
Number of eyes with adverse events
Time frame: Baseline up to 12 months
Time to adverse event
Time frame: Baseline up to 12 months
Number of brolucizumab injections prior to adverse event
Time frame: Baseline up to 12 months
1 secondary outcome
Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval
Time frame: Baseline up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular (Wet) Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status (time frame: Baseline up to 12 months). The study lists 5 primary outcomes in all. 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 28 Dec 2023.