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. 2022 Sep 12;12(9):e065001.
doi: 10.1136/bmjopen-2022-065001.

Eligibility for faricimab in a real-world neovascular age-related macular degeneration population: a cross-sectional study

Iréne Jern  1 , Sara Forsell  2 , Helena Norberg  3
Affiliations

Eligibility for faricimab in a real-world neovascular age-related macular degeneration population: a cross-sectional study

Iréne Jern et al. BMJ Open. .

Abstract

Objectives: To investigate the eligibility of a real-world neovascular age-related macular degeneration (nAMD) population for the TENAYA and LUCERNE trials (testing faricimab), and to compare the eligible real-world patients to trial participants.

Design, settings and participants: In this retrospective cross-sectional study, we used data from the Swedish Macula Registry (SMR) between 1 January 2017 and 31 December 2020. Persons were eligible if they fulfilled the main inclusion criteria in TENAYA and LUCERNE: (1) nAMD diagnosis, (2) treatment naïve, (3) ≥50 years and (4) best-corrected visual acuity (BCVA) of 78-24 letters.

Main outcome measures: Characteristics at the original visit of the eligible SMR population and baseline data from the clinical trials were compared.

Results: In total, 27 962 individuals with nAMD were registered in SMR. A total of 15 399 (55%) individuals were treatment naïve; of these, 15 368 (55%) were ≥50 years and 13 265 (47%) also had BCVA of 78-24 letters and fulfilled eligibility. Among treatment-naïve individuals, 86% were eligible and the BCVA criterion was the most common reason for non-eligibility. The eligible SMR population was significantly older than either TENAYA or LUCERNE. SMR included more women and patients with worse visual acuity than TENAYA, while SMR patients were diagnosed more quickly than LUCERNE.

Conclusions: Almost half of the real-world nAMD population in SMR fulfilled the main inclusion criteria of the TENAYA and LUCERNE trials. Among treatment-naïve individuals, 86% were eligible. Marginally differences were shown between the eligible SMR population and the trial populations. The SMR population were older and more similar to the population in LUCERNE than TENAYA.

Keywords: clinical trials; ophthalmology; public health.

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Conflict of interest statement

Competing interests: HN has received research and lecturer grants from Roche, and lecturer grants from AbbVie, Bayer and Pfizer. IJ and SF declare no conflicts of interests.

Figures

Figure 1
Figure 1
Selection of patients in the Swedish Macula Registry (SMR) between 2017 and 2020 eligible according to the main inclusion criteria in the TENAYA and LUCERNE trials. BCVA, best-corrected visual acuity; nAMD, neovascular age-related macular degeneration.
See this image and copyright information in PMC

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