Investigative Ophthalmology & Visual Science Cover Image for Volume 65, Issue 7
June 2024
Volume 65, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2024
Artificial Intelligence-Based Analysis of Drusen Volume in a Phase 2 Clinical Trial Evaluating RQC in Age-Related Macular Degeneration
Author Affiliations & Notes
  • Zibute Zaparackas
    Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
  • Nicholas Pfahler
    Ophthalmology and Visual Sciences, University of Illinois Chicago College of Medicine, Chicago, Illinois, United States
  • Stephanie Aman
    Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
  • Paul A Knepper
    Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
    Ophthalmology and Visual Sciences, University of Illinois Chicago College of Medicine, Chicago, Illinois, United States
  • Footnotes
    Commercial Relationships   Zibute Zaparackas None; Nicholas Pfahler None; Stephanie Aman None; Paul Knepper None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2024, Vol.65, 5699. doi:
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      Zibute Zaparackas, Nicholas Pfahler, Stephanie Aman, Paul A Knepper; Artificial Intelligence-Based Analysis of Drusen Volume in a Phase 2 Clinical Trial Evaluating RQC in Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2024;65(7):5699.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The risk of progression in intermediate dry age-related macular degeneration (AMD) is determined by the size of the largest drusen, i.e., drusen ≥125 µm and ≥250 µm are associated with a 25% and 50% risk of progression to advanced AMD, respectively. In this study, we evaluated the effect of curcumin or resveratrol, quercetin, and curcumin in combination (RQC) on drusen volume over two years in patients with intermediate AMD.

Methods : Participants with intermediate AMD (n=20) were randomly assigned to receive oral RQC (n=13) or curcumin (n=7) and followed for 2 years (NCT05062486). Drusen volume (mm3) was measured manually using SD-OCT images taken at baseline, 3, 6, 12, 18 and 24 months. An AI-based algorithm was used to identify and measure individual drusen across multiple scans and time points. Change from baseline was compared between RQC and curcumin as well as between medium (63-124 µm), large (125-249 µm) and extra-large (≥250 µm) drusen. A responder analysis was conducted with responders and non-responders defined as eyes with a decrease or increase of >10% from baseline.Visual acuity was measured using the ETDRS chart

Results : A total of 1,154 individual drusen were identified and 6,582 measurements made across the six time points. Among the drusen identified, 368 (32%) were classified as extra-large while 314 (27%) were classified as large. Mean total drusen volume decreased significantly in the RQC group (-0.023 mm3, -19.7%, p=0.02) but not the curcumin group (0.002 mm3, +12.1%). Change from baseline was significantly greater with RQC (p=0.03). Extra-large, large and medium drusen decreased by 38.7%, 24.8% and 3.1%, respectively. In the RQC group, 42% of eyes were classified as responder vs. 36% in the curcumin group. Inversely, 13% of RQC eyes were classified as non-responder versus 36% of curcumin eyes. Visual acuity mildly improved in both the RQC (+1.9 letters) and curcumin (+1.3) groups. There was no incidence of advanced AMD.

Conclusions : After 2 years, participants taking RQC had significantly reduced drusen volume, improved visual acuity, and no incidence of conversion to advanced AMD. These initial results from an ongoing phase 2 clinical trial for RQC are promising and indicate that RQC could be a safe and effective treatment for dry AMD.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

 

Responder analysis of drusen volume in AMD participants taking oral RQC or curcumin for 24 months.

Responder analysis of drusen volume in AMD participants taking oral RQC or curcumin for 24 months.

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