Age-related Macular Degeneration (AMD)NCT05146687
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
An observational study of Age-related Macular Degeneration (AMD), run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was the cross-sectional study to assess the period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019. 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?
- Aflibercept, Ranibizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 369,600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 11 Dec 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: The study included patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab)
Who may be able to join
- ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in 2019
- ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) code for treatment with an anti-VEGF agent (excluding brolucizumab) in 2019
- ≥18 years old in 2019
- ≥2 wet AMD-related office visits in 2019
Who cannot join
- ≥1 HCPCS code (J code) or NDC code for treatment with brolucizumab in 2019
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
This was the cross-sectional study to assess the period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019.
Read the detailed description
In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular AEs. The study was conducted using the Komodo Healthcare Map, and all results were based on the study period from 01/01/2018 to 12/31/2019.
Komodo Healthcare Map data from 01/01/2018 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.
- Identification period: Patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified
- Index date: 01/01/2019
- Study Period: 01/01/2018 to 12/31/2019
- Pre-index period: 01/01/2018 to 12/31/2018
- Post-index period: 01/01/2019 to 12/31/2019
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Aflibercept, Ranibizumab, Bevacizumab
- 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.
AfliberceptOther
Also called EYLEA®
intravitreal injection
RanibizumabOther
Also called LUCENTIS®
intravitreal injection
BevacizumabOther
Also called AVASTIN®; off-label use
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Patients/patient eyes who were treated only with aflibercept in 2019 Receives: Other: Aflibercept | |
| Ranibizumab | Patients/patient eyes who were treated only with ranibizumab in 2019 Receives: Other: Ranibizumab | |
| Bevacizumab | Patients/patient eyes who were treated only with bevacizumab in 2019 Receives: Other: Bevacizumab | |
| ≥2 Different Anti- VEFGFs | Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents
Period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019 was assessed.
Measured: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Secondary outcomes (9)
Age
Age information was reported
Measured: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Gender information
Gender information was reported
Measured: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients at various Patient Region
Patient regions: Northeast, Midwest, South, West, Unknown
Measured: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients with Insurance type
Private, Medicare, Medicare Advantage, Medicaid, Other
Measured: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Laterality of wet AMD: Unilateral, Bilateral
Measured: Index date (defined as the date of first injection - 01/01/2019)
Number of patient eyes with the Provider specialty on date of first anti-VEGF injection
The following types were included:
Retina specialist, General ophthalmologist
Measured: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patient eyes treated with anti-VEGF agent
The following types were included OD [eye, right], OS [eye, left], Unspecified
Measured: Index date (defined as the date of first injection - 01/01/2019)
Number of anti-VEGF injections
Anti-VEGF utilization in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab) over a one-year period was assessed. Measured at the patient level and patient-eye level.
Measured: over a one-year period from 01/012019 to 31/12/2019
Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)
The following types were included:
- Key ocular AEs
- IOI events
- RVO events
- Unspecified RO
- Autoimmune disorders (systemic lupus erythematosus [SLE], Behcet's disease, sarcoidosis, VKH disease, HLA-B27 syndromes, Drug hypersensitivity)
- RV without RO (RAO and/or RVO)
Measured: over a one-year period from 01/012019 to 31/12/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start15 Jul 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 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
- 369,600 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
- NCT05146687
- Sponsor's protocol ID
- CRTH258AUS19
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 16 Dec 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 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
- ClinicalTrials.gov ID
- NCT05146687
- Acronym / sponsor ID
- CRTH258AUS19
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- AMD,, brolucizumab,, anti-VEGF switchers,, treatment-naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369,600 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 7 Dec 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 the cross-sectional study to assess the period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019.
Detailed description
In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular AEs. The study was conducted using the Komodo Healthcare Map, and all results were based on the study period from 01/01/2018 to 12/31/2019.
Komodo Healthcare Map data from 01/01/2018 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.
- Identification period: Patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified
- Index date: 01/01/2019
- Study Period: 01/01/2018 to 12/31/2019
- Pre-index period: 01/01/2018 to 12/31/2018
- Post-index period: 01/01/2019 to 12/31/2019
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | – | Other: AfliberceptPatients/patient eyes who were treated only with aflibercept in 2019 |
| Ranibizumab | – | Other: RanibizumabPatients/patient eyes who were treated only with ranibizumab in 2019 |
| Bevacizumab | – | Other: BevacizumabPatients/patient eyes who were treated only with bevacizumab in 2019 |
| ≥2 Different Anti- VEFGFs | – | –Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab)
Key inclusion criteria (4 listed)
- ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in 2019
- ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) code for treatment with an anti-VEGF agent (excluding brolucizumab) in 2019
- ≥18 years old in 2019
- ≥2 wet AMD-related office visits in 2019
Key exclusion criteria (1 listed)
- ≥1 HCPCS code (J code) or NDC code for treatment with brolucizumab in 2019
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 |
|---|---|---|
| AfliberceptAlso: EYLEA®intravitreal injection | Other | Aflibercept |
| RanibizumabAlso: LUCENTIS®intravitreal injection | Other | Ranibizumab |
| BevacizumabAlso: AVASTIN®; off-label useintravitreal injection | Other | Bevacizumab |
Primary outcome
Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents
Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019 was assessed.
9 secondary outcomes
Age
Time frame: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Gender information
Time frame: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients at various Patient Region
Time frame: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients with Insurance type
Time frame: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Time frame: Index date (defined as the date of first injection - 01/01/2019)
Number of patient eyes with the Provider specialty on date of first anti-VEGF injection
Time frame: earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patient eyes treated with anti-VEGF agent
Time frame: Index date (defined as the date of first injection - 01/01/2019)
Number of anti-VEGF injections
Time frame: over a one-year period from 01/012019 to 31/12/2019
Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)
Time frame: over a one-year period from 01/012019 to 31/12/2019
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 16 Dec 2021.
- Results for CRTH258AUS19 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 4 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 16 Dec 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 Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents (time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019). 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 16 Dec 2021.