Prediction of Progression of Age-Related Macular Degeneration

NCT04640649 | Unknown

• 1 other identifier: 2019-0460
• Study Type: interventional
• Target: 278
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Macular Degeneration; Macular Degeneration, Wet; Macular Degeneration, Dry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Actual risk of conversion

  one year

• Number of visits

  one year

Study Arms (2)

Prediction Algorithm

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Algorithm prediction OTHER

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).

Prediction Algorithm

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Stanford University: collaborator
• Illinois Retina Associates: collaborator
• Bascom Palmer Eye Institute: collaborator

MeSH Terms

Conditions

Macular Degeneration; Wet Macular Degeneration; Geographic Atrophy

Interventions

Prediction Algorithms

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Study Officials

• Joelle A Hallak, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joelle A Hallak, PhD

CONTACT

3129960157; joelle@uic.edu

Kathleen Romond, MPH

CONTACT

kromon2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 23, 2020
• Study Start: November 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share