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<p>This study assessed and compensated for baseline differences in a randomized clinical trial of branched-chain amino acids (BCAAs) in patients with retinitis pigmentosa (RP). Seventy patients with eyes showing a mean deviation (MD) of −&#xa0;5.0 to −&#xa0;25.0 dB in the Humphrey visual-field (HFA 10-2) test were included. Participants were administered BCAAs (TK-98) or a placebo for 78 weeks. We evaluated the reliability of the baseline screening HFA test, analyzed HFA data from 13 weeks after treatment initiation, and conducted a covariate-adjusted analysis. Eyes showed paradoxical improvement as the start of the clinical trial approached. The proportion of eyes demonstrating visual-field improvement in the eligibility screening test was higher in the TK-98 group than in the placebo group. Analysis of HFA 10-2 data from 13 weeks post-treatment, excluding screening data, showed slower decrease rates of total point score (TPS) and MD in the TK-98 group. After covariate adjustment, TPS and MD reductions tended to be slower in the TK-98 group than in the placebo group. The eligibility screening visual-field test could be affected by psychological factors, such as patients’ concentration or motivation, leading to better-than-usual screening test results and making them less appropriate as baseline data.</p>

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Post hoc analysis of a randomized placebo-controlled trial suggests potential visual benefits of branched-chain amino acids in retinitis pigmentosa

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月1日

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  • Tomoko Hasegawa,
  • Hanako Ohashi Ikeda,
  • Hiroyasu Abe,
  • Yoko Amino,
  • Takayuki Nakagawa,
  • Harue Tada,
  • Manabu Miyata,
  • Akio Oishi,
  • Satoshi Morita,
  • Akitaka Tsujikawa

摘要

This study assessed and compensated for baseline differences in a randomized clinical trial of branched-chain amino acids (BCAAs) in patients with retinitis pigmentosa (RP). Seventy patients with eyes showing a mean deviation (MD) of − 5.0 to − 25.0 dB in the Humphrey visual-field (HFA 10-2) test were included. Participants were administered BCAAs (TK-98) or a placebo for 78 weeks. We evaluated the reliability of the baseline screening HFA test, analyzed HFA data from 13 weeks after treatment initiation, and conducted a covariate-adjusted analysis. Eyes showed paradoxical improvement as the start of the clinical trial approached. The proportion of eyes demonstrating visual-field improvement in the eligibility screening test was higher in the TK-98 group than in the placebo group. Analysis of HFA 10-2 data from 13 weeks post-treatment, excluding screening data, showed slower decrease rates of total point score (TPS) and MD in the TK-98 group. After covariate adjustment, TPS and MD reductions tended to be slower in the TK-98 group than in the placebo group. The eligibility screening visual-field test could be affected by psychological factors, such as patients’ concentration or motivation, leading to better-than-usual screening test results and making them less appropriate as baseline data.