June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Assessment of Progression of Geographic Atrophy in the FILLY Study
Author Affiliations & Notes
  • Allen Chiang
    Retina Service, Wills Eye Hospital, Lower Gwynedd, Pennsylvania, United States
  • David Lally
    New England Retina Consultants, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Allen Chiang, Apellis (F), Apellis (C), Genentech (F), Orbit Biomedical (C), Recens Medical (C), Regeneron (F); David Lally, Apellis (F), Apellis (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 4307. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Allen Chiang, David Lally; Assessment of Progression of Geographic Atrophy in the FILLY Study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):4307.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : To further assess progression of geographic atrophy (GA) by categories of change in GA in eyes receiving treatment with APL-2 or sham.

Methods : The FILLY trial was a Phase 2 multicenter, randomized, single-masked, sham-controlled clinical trial of APL-2 in patients with GA. Intravitreal injection of APL-2 was administered in the study eye monthly (M) or every other month (EOM) for 12 months. The primary efficacy endpoint was the change in square root GA lesion size from baseline to Month 12 compared to sham. Post hoc analysis was conducted to assess progression of GA (change in square root of GA lesion size from baseline) by quartiles in the overall dataset as well as by treatment groups. Only patients with observed data at Month 12 were included.

Results : Of 246 patients enrolled, 192 had efficacy endpoint observations at Month 12 and were included in this analysis. The overall mean change in GA lesion size was 1.46 (p< 0.05), 1.63 (p= 0.067), 2.19 mm2 in the M (n=67), EOM (n=58) and sham (S) (n=67), respectively. The quartile distribution (change from baseline GA lesion size) for the overall patient population was as follows: Q1: <0.13, Q2: 0.13-<0.27, Q3: 0.27-<0.41, Q4: >0.41 mm. Proportion of patients in each treatment group by quartile were: Q1 (M: 27%; EOM: 35%; S: 15%); Q2 (M: 30%; EOM: 28%; S: 18%); Q3 (M: 24%; EOM: 17%; S: 33%); Q4 (M: 19%; EOM: 21%; S: 34%). When assessed by each treatment group, quartile distributions demonstrated a shift in the sham group compared to the APL-2 treatment arms (Q1: <0.12 for M, <0.11 for EOM and <0.21 mm for S; Q4: >0.37 for M, >0.36 for EOM and >0.47 mm for S).

Conclusions : Consistent with the overall results, the proportion of patients with relatively smaller change in lesion size was higher in the APL-2 treatment arms compared to the sham control group suggestive of APL-2 control over GA progression. This finding was further supported by accelerated progression of GA lesion size in the sham group compared to the APL-2 groups.

This is a 2020 ARVO Annual Meeting abstract.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×