Age-related Macular Degeneration (AMD)NCT05082415
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
An observational study of Age-related Macular Degeneration (AMD), run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the 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
- 9,456 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2020to 15 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: Patients with wet AMD who initiated brolucizumab were analyzed in this study.
Who may be able to join
- ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
- ≥18 years old on the index date
- ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
- ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date
- o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.
- ≥1 follow-up visit after the index date
- ≥1 VA assessment on the index date or within 90 days prior to the index date
Who cannot join
- Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
- Unknown laterality of the index eye on the index date
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936-1080
About this study
This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.
Read the detailed description
IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in this study.
Identification period of the index date (index period): The patients fulfilling the selection criteria was identified
- Index date: Defined as the date of the earliest brolucizumab injection
- Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
- Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
- Post-index period: The period 180 days after the index date
- Conditions
- Age-related Macular Degeneration (AMD)
- Being tested
- Brolucizumab
- Keywords
- Brolucizumab,, intravitreal injection,, neovascular age-related macular degeneration,, visual acuity
- 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 patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
To assess IOI events observed after starting treatment with brolucizumab
Measured: Up to 6 months post brolucizumab injection
Secondary outcomes (24)
Age
Age information was reported
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Gender information
Gender information was reported
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients at various Patient Region
Patient regions: Northeast, Midwest, South, West, Unknown
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients with Insurance type
Insurance type: Medicare, Medicare Advantage, Medicaid, Commercial, Government, Military, No Insurance, Miscellaneous, Unknown
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Laterality of wet AMD: Unilateral, Bilateral
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Race/Ethnicity of the participants (patient level and eye level)
Caucasian, Black or African American, Asian, Other, Unknown
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of eyes with the concurrent eye disease
Types of concurrent eye diseases: ▪ Cataracts
- Posterior vitreous detachment
- Puckering of macula
- Macular hole
- Vitreomacular traction
- Glaucoma
- Amblyopia
- Papillitis
- Ischemic optic atrophy
- Diabetic retinopathy
- Diabetic macular edema
- Hypertensive retinopathy
- Pathologic myopia
- RAO
- RO
- RV
- Vitritis
- Endophthalmitis
- Uveitis
- Choroidal neovascularization (due to causes other than AMD, if possible, to determine)
- IOI
Measured: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with cataract status
Types: phakic, pseudophakic, aphakic
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with Concomitant ocular medications
Types:
- Corticosteroids
- Prednisone
- Prednisolone acetate
- Difluprednate
- Biologics
- Cyclosporine
- Methotrexate
- Ganciclovir
- Acyclovir
- Trifluridine
- Rituxan
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the history of ocular inflammation
The following categories were reported:
- No history of inflammation
- History of any ocular inflammation
- History of severe ocular inflammation
- History of anterior inflammation
- History of posterior inflammation
- History of IOI or endophthalmitis due to infections and other underlying disease (separate category)
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)
Included history of ocular inflammation or occlusion
Measured: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the Provider specialty
The following types were included:
Retina specialist, General ophthalmologist, Non-retina specialist, unknown
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patient eyes with the previous ocular surgeries or procedures
The following categories were included:
- Laser therapy
- Laser coagulation
- Photodynamic therapy
- IOP lowering surgeries (lasers, glaucoma filtering, non-filtering glaucoma)
- Cataract surgery
- Iridotomy
- Intraocular or refractive surgery (almost all IOP \& cataract surgeries)
- Previous penetrating keratoplasty, vitrectomy, or ocular radiation
- Previous panretinal photocoagulation
- Previous submacular surgery, other surgical intervention or laser treatment for AMD
Measured: 6 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Number of eyes treated with brolucizumab
The following types were included:
OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral)
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patient eyes with Visual Acuity (VA) reading
The following categories were included:
- Snellen: 20/10, 20/12-20/20, 20/25-20/40, 20/50-20/160, ≤20/200
- Approximate ETDRS letters
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days
Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated
Anti-VEGF treatment-naive vs prior-treated were measured at the eye level
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the prior treatment status
The following types were included:
off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of different prior anti-VEGF agents
The following categories were measured at the eye level:
0, 1, 2, ≥3
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of prior anti-VEGF injections
Total, per anti-VEGF agent were measured at the eye level)
- Continuous
- Categorical: <6, 6 to <12, 12 to <24, ≥24
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Duration of last anti-VEGF treatment
Total, per anti-VEGF agent; will be measured at the eye level
- All anti-VEGFs i. Continuous ii. Categorical: <6, 6 to <12, 12 to <24, ≥24 months
- Specific anti-VEGF iii. Continuous iv. Categorical: <6, 6 to <12, 12 to <24, ≥24 months
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time since wet Age-related macular degeneration (AMD) diagnosis
Patients were measured at the eye level
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time since any Age-related macular degeneration (AMD) diagnosis
Patients were measured at the eye level
Measured: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time from last anti-VEGF injection to index date (among switchers)
The following categories were measured:
- Continuous (days)
- Categorical (0-30, 31-60, 61-90, 91+ days)
Measured: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of ocular adverse events (AEs)
To assess the incidence of ocular AEs among patients treated with brolucizumab
Measured: Post-index period defined as the 180 days following therapy initiation, excluding index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start3 Jun 2020
- Primary completion15 Dec 2020
- Study completion15 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
- 9,456 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
- NCT05082415
- Sponsor's protocol ID
- CRTH258AUS15
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 27 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 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
- ClinicalTrials.gov ID
- NCT05082415
- Acronym / sponsor ID
- CRTH258AUS15
- Conditions
- Age-related Macular Degeneration (AMD)
- Keywords
- Brolucizumab,, intravitreal injection,, neovascular age-related macular degeneration,, visual acuity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,456 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 19 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.
This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.
Detailed description
IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in this study.
Identification period of the index date (index period): The patients fulfilling the selection criteria was identified
- Index date: Defined as the date of the earliest brolucizumab injection
- Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
- Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
- Post-index period: The period 180 days after the index date
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 (7 listed)
- ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
- ≥18 years old on the index date
- ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
- ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date
- o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.
Key exclusion criteria (2 listed)
- Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
- Unknown laterality of the index eye on the index date
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 patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
Time frame: Up to 6 months post brolucizumab injection
To assess IOI events observed after starting treatment with brolucizumab
24 secondary outcomes
Age
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Gender information
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients at various Patient Region
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients with Insurance type
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patients with Laterality of wet Age-related macular degeneration (AMD)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Race/Ethnicity of the participants (patient level and eye level)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of eyes with the concurrent eye disease
Time frame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with cataract status
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with Concomitant ocular medications
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the history of ocular inflammation
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)
Time frame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the Provider specialty
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patient eyes with the previous ocular surgeries or procedures
Time frame: 6 months prior to the index date ( index date defined as the date of first brolucizumab injection)
Number of eyes treated with brolucizumab
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of patient eyes with Visual Acuity (VA) reading
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days
Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of patient eyes with the prior treatment status
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of different prior anti-VEGF agents
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Number of prior anti-VEGF injections
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Duration of last anti-VEGF treatment
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time since wet Age-related macular degeneration (AMD) diagnosis
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time since any Age-related macular degeneration (AMD) diagnosis
Time frame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
Time from last anti-VEGF injection to index date (among switchers)
Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection
Number of ocular adverse events (AEs)
Time frame: Post-index period defined as the 180 days following therapy initiation, excluding index date
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 27 Oct 2021.
- Results for CRTH258AUS15 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 7 inclusion and 2 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 27 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 patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months (time frame: Up to 6 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 27 Oct 2021.