Age-related Macular Degeneration (AMD)NCT05037396
Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
An observational study of Age-related Macular Degeneration (AMD), run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- Brolucizumab
- Type of treatment
- Injection or infusion
- How many people
- 9,457 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 1 Aug 2020
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with wet AMD who initiated brolucizumab were analyzed in this study
Who may be able to join
- Patients with ≥1 brolucizumab injection
- Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date
Who cannot join
- There were no exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigational site
East Hanover, New Jersey, 07936-1080
About this study
Official title: Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study
This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.
Read the detailed description
This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns.
Setting and study population:
IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed.
Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020.
Index date: Defined as the date of the earliest brolucizumab injection.
Study Period: The period from 10/08/2018 to 03/31/2020.
Pre-index period: The period 12 months prior to the index date.
Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Brolucizumab
- Keywords
- AMD,, brolucizumab,, anti-VEGF switchers,, treatment-naive
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrolucizumabDrug
Also called BEOVU®
Participants received brolucizumab injection during the index period
| Study group | Role | What they receive |
|---|---|---|
| Brolucizumab | Participants received brolucizumab injection during the index period Receives: Drug: Brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months
To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab
Measured: Up to 4 months post brolucizumab injection
Secondary outcomes (25)
Age information
Age information was reported
Measured: Index date
Gender information
Gender information was reported
Measured: Index date
Number of participants: Regions
Northeast, North Central, South, West, Unknown
Measured: 12-month period prior to index
Number of participants: Insurance type
Private, Medicare, Medicare Advantage, Medicaid, Other
Measured: 12-month period prior to index
Number of participants: Laterality
Unilateral, Bilateral
Measured: 12-month period prior to index
Number of participants: Race
White, African American, Asian
Measured: 12-month period prior to index
Number of participants: Concurrent eye disease
Participants were measured at the eye level for the following eye diseases: Cataracts, Posterior vitreous detachment, Epiretinal membrane, Macular hole, Vitreomacular traction, Amblyopia, Pseudophakia, Glaucoma, Diabetic macular edema, Retinal vein occlusion, Diabetic retinopathy, Myopic choroidal neovascularization
Measured: 12-month period prior to index
Number of participants: Provider specialty
Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc)
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Encounter location (practice location)
Midwest, Northeast, South, West, Unknown
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Eye location of brolucizumab injections
e.g. OD [eye, right], OS [eye, left], Unspecified
Measured: 12-month period prior to index
Index Visual acuity (VA)
Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters).
Snellen VA ranges:
20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Wet AMD diagnosis for the fellow eye
Wet AMD diagnosis for the fellow eye as of the index date (Yes/No)
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Visual acuity of the fellow eye
Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters).
Snellen VA ranges:
20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of prior anti-VEGF treatments
Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported
Measured: 12-month period prior to index
Type of prior anti-VEGF treatment among switchers to brolucizumab
Type of anti-VEGF agent (aflibercept, bevacizumab, ranibizumab, unlicensed bevacizumab) used immediately prior to index were reported
Measured: 12-month period prior to index
Prior anti-VEGF treatment sequence
Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab)
Measured: 12-month period prior to index
Number of prior anti-VEGF injections received prior to brolucizumab index date
Total and Per treatment prior anti-VEGF injections received prior to brolucizumab index date were reported
Measured: 12-month period prior to index
Injection intervals for the eyes that had received anti-VEGF injections prior to index
Last injection interval, Average of last two injection intervals and Average of last three injection intervals were reported
Measured: 12-month period prior to index
Anti-VEGF treatment status for the fellow eye
Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Type of treatment for the fellow eye
Following type of treatment for the fellow eye will be reported: aflibercept, bevacizumab, ranibizumab, brolucizumab, unlicensed bevacizumab, or none)
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
The number of prior anti-VEGF treatments for the fellow eye
Number of prior anti-VEGF injections for the fellow eye will be reported: Continuous or Categorical (e.g. 0, 1, ≥2)
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of brolucizumab injections received per study eye
Early treatment patterns after brolucizumab index date in anti-VEGF switcher and anti-VEGF naive patient eyes were reported
Measured: Up to 4 months post index date
The last injection interval
The length of the interval between the final two injections was reported
Measured: Up to 4 months post index date
The first injection interval after switch compared to last injection interval with a prior treatment
Longer, same or shorter interval were reported
Measured: Up to 4 months post index date
Type of anti-VEGF agent initiated after switching from index brolucizumab
Thr type of anti-VEGF agent initiated in the first 3 months after switching from index brolucizumab. were reported
Measured: First 3 months after switching from index brolucizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start5 Mar 2020
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular Degeneration (AMD)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
- Retrospective
- Enrolment
- 9,457 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
- NCT05037396
- Sponsor's protocol ID
- CRTH258AUS12
- Status last verified
- Oct 2021
- First submitted
- 29 Jul 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study
- ClinicalTrials.gov ID
- NCT05037396
- Acronym / sponsor ID
- CRTH258AUS12
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- AMD,, brolucizumab,, anti-VEGF switchers,, treatment-naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,457 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 8 Sep 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 was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.
Detailed description
This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns.
Setting and study population:
IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed.
Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020.
Index date: Defined as the date of the earliest brolucizumab injection.
Study Period: The period from 10/08/2018 to 03/31/2020.
Pre-index period: The period 12 months prior to the index date.
Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brolucizumab | – | Drug: BrolucizumabParticipants received brolucizumab injection during the index period |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with wet AMD who initiated brolucizumab were analyzed in this study
Key inclusion criteria (2 listed)
- Patients with ≥1 brolucizumab injection
- Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date
Key exclusion criteria (1 listed)
- There were no exclusion criteria
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 |
|---|---|---|
| BrolucizumabAlso: BEOVU®Participants received brolucizumab injection during the index period | Drug | Brolucizumab |
Primary outcome
Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months
Time frame: Up to 4 months post brolucizumab injection
To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab
25 secondary outcomes
Age information
Time frame: Index date
Gender information
Time frame: Index date
Number of participants: Regions
Time frame: 12-month period prior to index
Number of participants: Insurance type
Time frame: 12-month period prior to index
Number of participants: Laterality
Time frame: 12-month period prior to index
Number of participants: Race
Time frame: 12-month period prior to index
Number of participants: Concurrent eye disease
Time frame: 12-month period prior to index
Number of participants: Provider specialty
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Encounter location (practice location)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Eye location of brolucizumab injections
Time frame: 12-month period prior to index
Index Visual acuity (VA)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Wet AMD diagnosis for the fellow eye
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Visual acuity of the fellow eye
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of prior anti-VEGF treatments
Time frame: 12-month period prior to index
Type of prior anti-VEGF treatment among switchers to brolucizumab
Time frame: 12-month period prior to index
Prior anti-VEGF treatment sequence
Time frame: 12-month period prior to index
Number of prior anti-VEGF injections received prior to brolucizumab index date
Time frame: 12-month period prior to index
Injection intervals for the eyes that had received anti-VEGF injections prior to index
Time frame: 12-month period prior to index
Anti-VEGF treatment status for the fellow eye
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Type of treatment for the fellow eye
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
The number of prior anti-VEGF treatments for the fellow eye
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of brolucizumab injections received per study eye
Time frame: Up to 4 months post index date
The last injection interval
Time frame: Up to 4 months post index date
The first injection interval after switch compared to last injection interval with a prior treatment
Time frame: Up to 4 months post index date
Type of anti-VEGF agent initiated after switching from index brolucizumab
Time frame: First 3 months after switching from index brolucizumab
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 12 Oct 2021.
- Results for CRTH258AUS12 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
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 Age-related Macular Degeneration (AMD), 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 2 inclusion and 1 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 12 Oct 2021. 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?
Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months (time frame: Up to 4 months post brolucizumab injection). 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 12 Oct 2021.