NCT04640649|Unknown
Prediction of Progression of Age-Related Macular Degeneration
A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration
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A Novel Approach to Personalized Prediction of Progression of Age-Related Macular Degeneration
Sponsor study identifier
interventional
278
0 countries
N/A
Study Start
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 8, 2020
Actual (reported)November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 23, 2020
Actual (reported)July 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
one year
Actual risk of conversion
one year
Number of visits
one year
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.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Joelle A Hallak, PhD
University of Illinois at Chicago
First Submitted
October 8, 2020
First Posted
November 23, 2020
Study Start
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2021
Improving Vision in Adults With Macular Degeneration
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 23, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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