Neovascular Age-related Macular DegenerationNCT06178770
Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up
An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- How many people
- 414 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 12 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
- Patients with a diagnosis of nAMD.
- Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
- Patients remained on brolucizumab for at least 12 months.
- Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
- For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
- For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period.
Who cannot join
- For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
- Eyes missing bilaterality information in their nAMD diagnosis.
- Eyes missing bilaterality information in their brolucizumab injections.
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.
- Keywords
- nAMD
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 |
|---|---|---|
| Overall cohort | Not described | |
| 12-month BRO cohort | Not described | |
| 18-month BRO cohort | Not described | |
| 12-month ALT cohort | Not described | |
| 18-month ALT cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts
Measured: Baseline, Month 12
Secondary outcomes (19)
Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts
Measured: Baseline, Month 18
Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)
Measured: Baseline, Months 12 and 18
Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)
Measured: Baseline, Months 12 and 18
Age
Measured: Baseline
Gender
Measured: Baseline
Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)
Measured: Baseline, Month 12 and Month 18
Anti-VEGF treatment status
Measured: Baseline
Last injection interval before switch to brolucizumab in prior-treated eyes
Measured: Baseline
Central macular thickness (CMT)
Measured: Baseline, Month 12 and Month 18
Intraretinal fluid (IRF)
Measured: Baseline
Subretinal fluid (SRF)
Measured: Baseline
Pigment epithelial detachment (PED)
Measured: Baseline
Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort)
Measured: Baseline, Month 12
Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection
Measured: Up to 3 years
Median time (days) from first brolucizumab injection to AE
Measured: Up to 3 years
Median time (days) from last brolucizumab injection pre-AE to AE
Measured: Up to 3 years
Median time (days) from AE to resolution
Measured: Up to 3 years
Median number of brolucizumab injections pre-AE including the index injection
Measured: Up to 3 years
Proportion of patients in different levels of vision recovery after AE resolution
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Dec 2021
- Primary completion12 Dec 2022
- Study completion12 Dec 2022
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 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
- 414 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
- NCT06178770
- Sponsor's protocol ID
- CRTH258A2018
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up
- ClinicalTrials.gov ID
- NCT06178770
- Acronym / sponsor ID
- CRTH258A2018
- Keywords
- nAMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 21 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 retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Overall cohort | – | – |
| 12-month BRO cohort | – | – |
| 18-month BRO cohort | – | – |
| 12-month ALT cohort | – | – |
| 18-month ALT cohort | – | – |
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 (6 listed)
- Patients with a diagnosis of nAMD.
- Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
- Patients remained on brolucizumab for at least 12 months.
- Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
- For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
Key exclusion criteria (3 listed)
- For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
- Eyes missing bilaterality information in their nAMD diagnosis.
- Eyes missing bilaterality information in their brolucizumab injections.
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
Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts
Time frame: Baseline, Month 12
19 secondary outcomes
Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts
Time frame: Baseline, Month 18
Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)
Time frame: Baseline, Months 12 and 18
Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort)
Time frame: Baseline, Months 12 and 18
Age
Time frame: Baseline
Gender
Time frame: Baseline
Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)
Time frame: Baseline, Month 12 and Month 18
Anti-VEGF treatment status
Time frame: Baseline
Last injection interval before switch to brolucizumab in prior-treated eyes
Time frame: Baseline
Central macular thickness (CMT)
Time frame: Baseline, Month 12 and Month 18
Intraretinal fluid (IRF)
Time frame: Baseline
Subretinal fluid (SRF)
Time frame: Baseline
Pigment epithelial detachment (PED)
Time frame: Baseline
Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort)
Time frame: Baseline, Month 12
Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection
Time frame: Up to 3 years
Median time (days) from first brolucizumab injection to AE
Time frame: Up to 3 years
Median time (days) from last brolucizumab injection pre-AE to AE
Time frame: Up to 3 years
Median time (days) from AE to resolution
Time frame: Up to 3 years
Median number of brolucizumab injections pre-AE including the index injection
Time frame: Up to 3 years
Proportion of patients in different levels of vision recovery after AE resolution
Time frame: Up to 3 years
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 21 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 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 6 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 21 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?
Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts (time frame: Baseline, 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 21 Dec 2023.