Prediction of Progression of Age-Related Macular Degeneration
NCT ID: NCT04640649
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
278 participants
INTERVENTIONAL
2020-11-30
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prediction Algorithm
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.
Algorithm prediction
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).
Control
Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Algorithm prediction
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* \> 45 years of age,
* willingness to participate through a signed consent form.
Exclusion Criteria
* 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
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Illinois Retina Associates
OTHER
Bascom Palmer Eye Institute
OTHER
University of Illinois at Chicago
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Joelle Hallak
Assistant Professor, Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joelle A Hallak, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-0460
Identifier Type: -
Identifier Source: org_study_id