Clinical Trial Emulation of the Catt Using Data from the Iris® Registry (INTELLIGENT RESEARCH IN SIGHT) Using Exact Matching and Inverse Probability Weighting
Author(s)
Fevrier H1, LaPrise A2, Mbagwu M3, Borkar D4
1Verana Health, Brooklyn, NY, USA, 2Verana Health, San Francisco, CA, USA, 3Verana Health, Stanford University School of Medicine, Department of Veterans Affairs, San Jose, CA, USA, 4Duke University School of Medicine, Durham, NC, USA
Presentation Documents
OBJECTIVES: The Comparison of Age-Related Macular Degeneration (AMD) Treatment Trials (CATT) studied anti-VEGF treatment patterns and outcomes. As real-world treatment is less stringent than trials, different methods may be used to compare trials to real-world data (RWD). To evaluate differences in treatment arms from CATT and two real-world control arms receiving anti-VEGF as needed (prn), two matching methodologies were explored.
METHODS: Non-imaging CATT criteria ascertainable from RWD were applied to American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) patients from 1/1/2015 to 12/31/2019. Treatment-naive eyes injected prn with either bevacizumab or ranibizumab for one year were matched to CATT patients through exact matching (age, sex, baseline visual acuity [VA]) and inverse probability weighting (IPW). Baseline characteristics, treatment, and VA outcomes from the RWD control cohorts were compared to CATT treatment arms.
RESULTS: Exact matching had 261 and 281 eligible eyes for ranibizumab and bevacizumab, respectively. IPW yielded 427 and 771 eyes for ranibizumab and bevacizumab, respectively. Both methods produced similar baseline characteristics, number of injections received, and VA. Compared to CATT cohorts, RWD injection estimates were consistently lower. There were 3.29 fewer ranibizumab injections using both methods while there were 4.95 and 4.69 fewer bevacizumab injections using IPW and exact matching, respectively, compared to CATT. IPW and exact matching also yielded gains in VA in the ranibizumab RWD cohort (5.67 and 6.99 letters, respectively) and the bevacizumab RWD cohort (5.88 and 5.75 letters, respectively) as compared to the trial.
CONCLUSIONS: The approach taken to adjust for differences across trial and RWD cohorts may impact findings. Exact matching and IPW yielded consistent clinical interpretations demonstrating that results were not sensitive to the methodology selected despite changes in the analyzed cohort size thus increasing confidence in the results observed.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Code
RWD133
Topic
Clinical Outcomes, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Clinical Trials, Comparative Effectiveness or Efficacy, Registries, Reproducibility & Replicability
Disease
No Additional Disease & Conditions/Specialized Treatment Areas