Age-related Macular Degeneration (AMD)NCT05066685
Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program
An observational study of Age-related Macular Degeneration (AMD), run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was generated to describe their baseline demographic and clinical characteristics. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Age-related Macular Degeneration (AMD)
- What is being tested?
- All participants
- How many people
- 18,457 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 25 Sep 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included patients with wet AMD
Who may be able to join
- Patients were enrolled in the brolucizumab PSS program
- ≥19 years old
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was generated to describe their baseline demographic and clinical characteristics.
Read the detailed description
The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program.
PSS data was obtained from patients with wet AMD who enrolled in the program for the index period 10/10/2019 to 04/30/2020.
- Identification period of the index period: 10/10/2019 to 04/30/2020
- Index date: Date of enrollment in the PSS program
- Study Period: 10/10/2019 to 04/30/2020
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- All participants
- Keywords
- Primary plan,, AMD characteristics,, brolucizumab
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All participantsOther
All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program Receives: Other: All participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Primary plan type
The primary plan type for patients with wet AMD enrolled in the brolucizumab patient support services program were reported. The primary Plan type include commercial, government or other insurance.
Measured: Index date defined as the date of enrollment in the PSS program
Secondary outcomes (7)
Age
Age information of patients enrolled in the brolucizumab PSS program was reported
Measured: Index date defined as the date of enrollment in the PSS program
Gender
Gender information of patients enrolled in the brolucizumab PSS program was reported
Measured: Index date defined as the date of enrollment in the PSS program
Patient region (by state)
Distribution of patients across US states
Measured: Index date defined as the date of enrollment in the PSS program
Provider region (by state)
Number of providers and their distribution across US states
Measured: Index date defined as the date of enrollment in the PSS program
Insurance coverage
The insurance coverage details for all the patients with wet AMD was reported
Measured: Index date defined as the date of enrollment in the PSS program
Number of patients with Secondary plan type
The secondary plan type for patients with wet AMD enrolled in the brolucizumab patient support services program were reported. The secondary plan included commercial, government or other insurance
Measured: Index date defined as the date of enrollment in the PSS program
Disease Status
The eye disease status of all the patients were reported. Disease status was categorized as Right eye, left eye, or bilateral
Measured: Index date defined as the date of enrollment in the PSS program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start11 Aug 2020
- Primary completion25 Sep 2020
- Study completion25 Sep 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
- 18,457 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
- NCT05066685
- Sponsor's protocol ID
- CRTH258AUS18
- Status last verified
- Oct 2021
- First submitted
- 23 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program
- ClinicalTrials.gov ID
- NCT05066685
- Acronym / sponsor ID
- CRTH258AUS18
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- Primary plan,, AMD characteristics,, brolucizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,457 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 4 Oct 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.
The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was generated to describe their baseline demographic and clinical characteristics.
Detailed description
The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program.
PSS data was obtained from patients with wet AMD who enrolled in the program for the index period 10/10/2019 to 04/30/2020.
- Identification period of the index period: 10/10/2019 to 04/30/2020
- Index date: Date of enrollment in the PSS program
- Study Period: 10/10/2019 to 04/30/2020
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: All participantsAll the particpants enrolled in the brolucizumab Patient Support Services (PSS) program |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients with wet AMD
Key inclusion criteria (2 listed)
- Patients were enrolled in the brolucizumab PSS program
- ≥19 years old
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| All participantsAll the particpants enrolled in the brolucizumab Patient Support Services (PSS) program | Other | All Participants |
Primary outcome
Number of patients with Primary plan type
Time frame: Index date defined as the date of enrollment in the PSS program
The primary plan type for patients with wet AMD enrolled in the brolucizumab patient support services program were reported. The primary Plan type include commercial, government or other insurance.
7 secondary outcomes
Age
Time frame: Index date defined as the date of enrollment in the PSS program
Gender
Time frame: Index date defined as the date of enrollment in the PSS program
Patient region (by state)
Time frame: Index date defined as the date of enrollment in the PSS program
Provider region (by state)
Time frame: Index date defined as the date of enrollment in the PSS program
Insurance coverage
Time frame: Index date defined as the date of enrollment in the PSS program
Number of patients with Secondary plan type
Time frame: Index date defined as the date of enrollment in the PSS program
Disease Status
Time frame: Index date defined as the date of enrollment in the PSS program
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 CRTH258AUS18 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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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 with Primary plan type (time frame: Index date defined as the date of enrollment in the PSS program). 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.