Prediction of Progression of Age-Related Macular Degeneration

University of Illinois

Status: Unknown

Conditions: Macular Degeneration; Macular Degeneration, Dry; Macular Degeneration, Wet

Treatments: Other: Algorithm prediction

Study type: Interventional

Funder types: Other

Identifiers

NCT04640649

2019-0460

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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278 participants in 2 patient groups

Prediction Algorithm

Experimental group

Description:

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.

Treatment:

Other: Algorithm prediction

Control

No Intervention group

Description:

Patients in the control arm will have a screening visit, then will come for one follow-up visit, at 6 months (standard care) only.