AMDIBPAMDNCT04537143
Image Biomarkers for Progression of AMD
An observational study of AMD, run by Doheny Image Reading Center.
Trial summary
To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AMD
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Half control, half AMD eyes
Who may be able to join
- being male or female
- at least 18 years of age
- varied ethnic backgrounds (different ethnic groups have different structures of eye anatomy and we must be able to make ethnic subgroups to account for these differences)
Who cannot join
- vulnerable patients
- patients under 18
- pregnant (we exclude pregnant women because pregnancy often can alter eye anatomy)
- economically and educationally disadvantaged
- decision impaired
- homeless people.
About this study
Official title: Understanding Imaging Biomarkers That Predict the Progression of Age-Related Macular Degeneration on Multi-modal Novel Retinal Technologies
To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.
Read the detailed description
The qualitative studies will explore use of OCT Angiography (OCTA), Swept Source OCT (SS-OCT), Ultra-Wide Field Fluorescein Angiography (UWF-FA), Adaptive Optic Scanning Laser Ophthalmoscopy (AO-SLO), Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO), Retro Mode Imaging (RMI) and other novel technologies for the retinal diagnosis. Morphologic qualitative IBs described in the literature like macular neovascularization pattern, retinal tubulations, choriocapillary preservation, retinal pigment epithelium atrophy, drusen patterns, etc as well as other IBPAMD original IBs classified in morphopathogenic categories like IBs related-to-MNV, IBs related-to-atrophy, IBs related-to macular chorio-retinal architecture, etc are analyzed in granular fashion by multi-modal imaging approach before and after different treatments for AMD.
The quantitative IBs assessment will be done in dual mode - classic and original to the IBPAMD trial. The lesions are quantitatively assessed on one hand, by using the classic measurements of the greatest diameter, total lesions area, vessels density, fractal dimension, etc, based on the classic concept of measurements expressed in absolute values (mm, mm2 or pixels). The same lesions are quantitatively assessed by using the original IBPAMD algorithm and software (SITE-app) that introduce a new concept in the quantification of the retinal lesions, the assessment of differences reported to the baseline.
- Conditions
- AMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Non-AMD eyes | |
| AMD | AMD eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
ONH diameter
Measured: 1-2 year FU
area of MNV
Measured: 1-2 year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Funding for staff no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doheny Image Reading Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Marion, Doheny Image Reading Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537143
- Sponsor's protocol ID
- Narcisa
- Acronym
- IBPAMD
- Status last verified
- Sep 2020
- First submitted
- 28 Aug 2020
- Last updated
- 28 Sep 2020
- Results posted
- 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 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Imaging Biomarkers That Predict the Progression of Age-Related Macular Degeneration on Multi-modal Novel Retinal Technologies
- ClinicalTrials.gov ID
- NCT04537143
- Acronym / sponsor ID
- IBPAMD / Narcisa
- Conditions
- AMD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding for staff no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Doheny Image Reading CenterUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 3 Sep 2020 (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.
To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.
Detailed description
The qualitative studies will explore use of OCT Angiography (OCTA), Swept Source OCT (SS-OCT), Ultra-Wide Field Fluorescein Angiography (UWF-FA), Adaptive Optic Scanning Laser Ophthalmoscopy (AO-SLO), Fluorescence Lifetime Imaging Ophthalmoscopy (FLIO), Retro Mode Imaging (RMI) and other novel technologies for the retinal diagnosis. Morphologic qualitative IBs described in the literature like macular neovascularization pattern, retinal tubulations, choriocapillary preservation, retinal pigment epithelium atrophy, drusen patterns, etc as well as other IBPAMD original IBs classified in morphopathogenic categories like IBs related-to-MNV, IBs related-to-atrophy, IBs related-to macular chorio-retinal architecture, etc are analyzed in granular fashion by multi-modal imaging approach before and after different treatments for AMD.
The quantitative IBs assessment will be done in dual mode - classic and original to the IBPAMD trial. The lesions are quantitatively assessed on one hand, by using the classic measurements of the greatest diameter, total lesions area, vessels density, fractal dimension, etc, based on the classic concept of measurements expressed in absolute values (mm, mm2 or pixels). The same lesions are quantitatively assessed by using the original IBPAMD algorithm and software (SITE-app) that introduce a new concept in the quantification of the retinal lesions, the assessment of differences reported to the baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Non-AMD eyes |
| AMD | – | –AMD eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Half control, half AMD eyes
Key inclusion criteria (3 listed)
- being male or female
- at least 18 years of age
- varied ethnic backgrounds (different ethnic groups have different structures of eye anatomy and we must be able to make ethnic subgroups to account for these differences)
Key exclusion criteria (6 listed)
- vulnerable patients
- patients under 18
- pregnant (we exclude pregnant women because pregnancy often can alter eye anatomy)
- economically and educationally disadvantaged
- decision impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ONH diameter
Time frame: 1-2 year FU
area of MNV
Time frame: 1-2 year FU
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of AMD, run by Doheny Image Reading Center.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
ONH diameter (time frame: 1-2 year FU). The study lists 2 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 28 Sep 2020.