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

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

Abstract 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...

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Main Authors: Tomoko Hasegawa, Hanako Ohashi Ikeda, Hiroyasu Abe, Yoko Amino, Takayuki Nakagawa, Harue Tada, Manabu Miyata, Akio Oishi, Satoshi Morita, Akitaka Tsujikawa
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Scientific Reports
Subjects:
Branched-chain amino acid
Humphrey visual-field test
Placebo effect
Retinitis pigmentosa
Online Access:https://doi.org/10.1038/s41598-025-07341-7
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Summary:Abstract 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.
ISSN:2045-2322

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