Intraocular InflammationNCT05657158
Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion
An observational study of Intraocular Inflammation and Retinal Vascular Occlusion, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Intraocular Inflammation, Retinal Vascular Occlusion
- What is being tested?
- Brolucizumab
- How many people
- 198 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Aug 2021to 4 Jan 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As this study used secondary data from Novartis Patient Safety database, there was no specified set of subject population in this study and all cases with event of interest and available images were retrieved.
Who may be able to join
- participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Imaging and Clinical Features From Patients Treated With Brolucizumab in Post-marketing Setting With Reports of Intraocular Inflammation and/or Retinal Vascular Occlusion
This non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.
Read the detailed description
The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.
Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists [TFUs]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.
All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).
- Being tested
- Brolucizumab
- Keywords
- Brolucizumab, Neovascular age-related macular degeneration, occlusive retinal vasculitis, retinal vasculitis, RV, retinal vascular occlusion, RO, ocular images
- Medical subject headings
- Uveitis, Retinal Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrolucizumabOther
Participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre were included
| Study group | Role | What they receive |
|---|---|---|
| Brolucizumab | brolucizumab in routine clinical practice Receives: Other: Brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye case classification based on imaging data
Eye case classification based on imaging data is provided:
- IOI: intraocular inflammation (posterior segment only)
- RV: Retinal vasculitis
- RO: Retinal vascular occlusion
- Not assessable: image quality concerns prevented grading
- None: no imaging features of IOI, RV, or RO
Measured: throughout the study period of 5 months
Number of eye cases by anatomical location and sub-location
Number of eye cases by anatomical location and sub-location is provided:
- Retina: Vascular and general)
- Vitreous
- Choroid
- Optic nerve
Measured: throughout the study period of 5 months
Number of eye cases by occlusion type by reading center eye case classification
Occlusion type by reading center eye case classification is provided:
- Central
- Branch
- Peripheral
Measured: throughout the study period of 5 months
Number of eye cases by Anatomical location in relation to macula
Number of eye cases by Anatomical location in relation to macula is provided:
Measured: throughout the study period of 5 months
Number of eye cases by extent of involvement of the retinal arterial and vein occlusion
Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided
Measured: throughout the study period of 5 months
Number of eye cases by grading variables per imaging modality by reading center eye case classification
Number of eye cases by grading variables per imaging modality by reading center eye case classification is provided
Measured: throughout the study period of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start23 Aug 2021
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular InflammationStudies 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
- 198 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
- NCT05657158
- Sponsor's protocol ID
- CRTH258A2404
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Imaging and Clinical Features From Patients Treated With Brolucizumab in Post-marketing Setting With Reports of Intraocular Inflammation and/or Retinal Vascular Occlusion
- ClinicalTrials.gov ID
- NCT05657158
- Acronym / sponsor ID
- CRTH258A2404
- Keywords
- Brolucizumab, Neovascular age-related macular degeneration, occlusive retinal vasculitis, retinal vasculitis, RV, retinal vascular occlusion, RO, ocular images
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 20 Dec 2022 (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 non-interventional descriptive study was undertaken to better understand the most common imaging features associated with inflammation arising in the post-marketing setting when brolucizumab was prescribed in routine clinical practice.
Detailed description
The purpose of this retrospective study analysis was to better characterize the risk of inflammatory events arising from use of brolucizumab in routine clinical practice through analysis of independently reviewed ocular imaging data obtained from cases with reports of intraocular inflammation (IOI), retinal vasculitis (RV) and/or Retinal vascular occlusion (RO) and to provide a description of these features.
Whenever an AE report pertaining to RV and/or RO was reported to Novartis Patient Safety, a follow-up check list (targeted follow-up checklists [TFUs]) was sent by Novartis to the reporter. The reporter was encouraged to share all available images obtained as part of clinical practice, irrespective of the timing or event (i.e. images before, during, and after event could be provided). The focus and main efforts of this data collection was on adverse events of RV and/or RO; for other IOI only events, the images were not actively requested in the case documentation process, however in some cases these were spontaneously reported by the reporter.
All images obtained from Feb 2020 up to 31 Jan 2021 were reviewed in a standardized manner by an external reading center. Dedicated grading lists were developed for each of the image modalities: Fluorescein Angiography (FA), Fundus Photography (FP), Indocyanine Green Angiography (ICGA), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brolucizumab | – | Other: Brolucizumabbrolucizumab in routine clinical practice |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As this study used secondary data from Novartis Patient Safety database, there was no specified set of subject population in this study and all cases with event of interest and available images were retrieved.
Key inclusion criteria (1 listed)
- participants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BrolucizumabParticipants with cases of RV and/or RO reported to Novartis Patient Safety following brolucizumab use in routine clinical practice for which images were provided to Novartis and read by the Reading Centre were included | Other | Brolucizumab |
Primary outcome
Eye case classification based on imaging data
Time frame: throughout the study period of 5 months
Eye case classification based on imaging data is provided: * IOI: intraocular inflammation (posterior segment only) * RV: Retinal vasculitis * RO: Retinal vascular occlusion * Not assessable: image quality concerns prevented grading * None: no imaging features of IOI, RV, or RO
Number of eye cases by anatomical location and sub-location
Time frame: throughout the study period of 5 months
Number of eye cases by anatomical location and sub-location is provided: * Retina: Vascular and general) * Vitreous * Choroid * Optic nerve
Number of eye cases by occlusion type by reading center eye case classification
Time frame: throughout the study period of 5 months
Occlusion type by reading center eye case classification is provided: * Central * Branch * Peripheral
Number of eye cases by Anatomical location in relation to macula
Time frame: throughout the study period of 5 months
Number of eye cases by Anatomical location in relation to macula is provided:
Number of eye cases by extent of involvement of the retinal arterial and vein occlusion
Time frame: throughout the study period of 5 months
Number of eye cases by Extent of involvement of the retinal arterial and vein occlusion is provided
Number of eye cases by grading variables per imaging modality by reading center eye case classification
Time frame: throughout the study period of 5 months
Number of eye cases by grading variables per imaging modality by reading center eye case classification is provided
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 20 Dec 2022.
- 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 Intraocular Inflammation and Retinal Vascular Occlusion, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 1 inclusion and 0 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 20 Dec 2022. 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 Switzerland. 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?
Eye case classification based on imaging data (time frame: throughout the study period of 5 months). The study lists 6 primary outcomes in all. 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 20 Dec 2022.