An interventional study of Algorithm prediction in Macular Degeneration, Macular Degeneration, Wet and Macular Degeneration, Dry, sponsored by University of Illinois at Chicago. Status unknown. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2020-11-23.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Diagnostic
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.
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 278 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
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.
Other: Algorithm prediction
Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.
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).
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
Time frame: one year
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.
Time frame: 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
Time frame: one year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago