Macular Degeneration Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 278 |
Est. completion date | December 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago | Bascom Palmer Eye Institute, Illinois Retina Associates, Stanford University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | one year | |
Secondary | Number of visits | Number of visits will be compared between the test arm and the control arm of patients who progression to wet AMD | one year |
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