Macular DegenerationNCT04640649
Prediction of Progression of Age-Related Macular Degeneration
A study testing Algorithm prediction in people with Macular Degeneration and Macular Degeneration, Wet, run by University of Illinois Chicago.
Trial summary
The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Macular Degeneration, Macular Degeneration, Wet, Macular Degeneration, Dry
- What is being tested?
- Algorithm prediction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2021
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-neovascular AMD at baseline in at least one eye with no signs of GA,
- > 45 years of age,
- willingness to participate through a signed consent form.
Who cannot join
- Pregnant women and vulnerable populations
- Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1.
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
Trial locations and contacts
No sites are listed yet.
Kathleen Romond, MPH contact
About this study
Official title: A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration
The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. The test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data.
This work will advance the AMD field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.
Read the detailed description
More than 90% of patients with advanced AMD have severe vision loss. Predicting AMD progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (CNV) event and geographic atrophy (GA) monitoring can greatly improve visual outcomes. Patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. Previous work has determined the risk factors for AMD progression based on drusen features in fundus photos, Optical Coherence Tomography (OCT) and from genetic factors. However, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals.
In this study we will recruit patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion. We will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. Outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.
- Being tested
- Algorithm prediction
- Medical subject headings
- Macular Degeneration, Wet Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm predictionOther
Patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion will be randomly assigned to a test group or control group. The test group will have their baseline data analyzed by an algorithm to predict the probability of conversion to wet AMD. If the probability is high for conversion at or before 3 months, patients will have earlier follow-up care than the control group (standard follow-up care every 6 months).
| Study group | Role | What they receive |
|---|---|---|
| Prediction Algorithm | Experimental | Patients in the test arm will have a screening visit, then will come for two follow-up visits, at 3 months (if the algorithm determines high-risk of conversion within 3 months) and 6 months. Receives: Other: Algorithm prediction |
| Control | No intervention | Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD
Measured: one year
Secondary outcomes (2)
Actual risk of conversion
The actual risk/ of conversion to wet AMD will be calculated for each eye that progressed using regression analysis. This risk will be compared to the risk that the algorithm predicted.
Measured: one year
Number of visits
Number of visits will be compared between the test arm and the control arm of patients who progression to wet AMD
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Illinois Retina Associates, Bascom Palmer Eye Institute
- Responsible party
- Principal investigator, Joelle Hallak, University of Illinois Chicago
- Investigators
- Joelle A Hallak, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640649
- Sponsor's protocol ID
- 2019-0460
- Status last verified
- Nov 2020
- First submitted
- 8 Oct 2020
- Last updated
- 23 Nov 2020
- 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 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04640649
- Acronym / sponsor ID
- 2019-0460
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Stanford University, Illinois Retina Associates, Bascom Palmer Eye Institute
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Nov 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.
The goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized AMD progression prediction models. Early and intermediate AMD patients will be recruited and randomly assigned them to a control or test group. The test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data.
This work will advance the AMD field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.
Detailed description
More than 90% of patients with advanced AMD have severe vision loss. Predicting AMD progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (CNV) event and geographic atrophy (GA) monitoring can greatly improve visual outcomes. Patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. Previous work has determined the risk factors for AMD progression based on drusen features in fundus photos, Optical Coherence Tomography (OCT) and from genetic factors. However, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals.
In this study we will recruit patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion. We will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. Outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediction Algorithm | Experimental | Other: Algorithm predictionPatients in the test arm will have a screening visit, then will come for two follow-up visits, at 3 months (if the algorithm determines high-risk of conversion within 3 months) and 6 months. |
| Control | No intervention | –Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-neovascular AMD at baseline in at least one eye with no signs of GA,
- > 45 years of age,
- willingness to participate through a signed consent form.
Key exclusion criteria (3 listed)
- Pregnant women and vulnerable populations
- Participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to Day 1.
- Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid
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 |
|---|---|---|
| Algorithm predictionPatients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion will be randomly assigned to a test group or control group. The test group will have their baseline data analyzed by an algorithm to predict the probability of conversion to wet AMD. If the probability is high for conversion at or before 3 months, patients will have earlier follow-up care than the control group (standard follow-up care every 6 months). | Other | Prediction Algorithm |
Primary outcome
Visual Acuity
Time frame: one year
The primary outcome measure will be the difference in visual acuity between test and control patients in those who progressed to late stage AMD
2 secondary outcomes
Actual risk of conversion
Time frame: one year
Number of visits
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 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.
Kathleen Romond, MPH contact
Joelle A Hallak, PhD principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm prediction in people with Macular Degeneration and Macular Degeneration, Wet, run by University of Illinois Chicago.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joelle A Hallak, PhD (3129960157, joelle@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: one year). 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 23 Nov 2020.