April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Microperimetry Shows Protection of Central Vision in Retinitis Pigmentosa Patients treated with UF-021: a Phase 2 Study (JapicCTI-090748)
Author Affiliations & Notes
  • Shuichi Yamamoto
    Department of Ophthalmology, Chiba University Graduate School of Medicine, Chiba, Japan
  • Takeshi Sugawara
    Department of Ophthalmology, Chiba University Graduate School of Medicine, Chiba, Japan
  • Mitsuru Nakazawa
    Department of Ophthalmology, Hirosaki Univ Grad Sch of Med, Hirosaki-shi, Japan
  • Shigeki Machida
    Dept of Ophthalmology, Iwate Medical University, Morioka, Japan
  • Akira Murakami
    Dept of Ophthalmology, Juntendo Univ School of Med, Bunkyo-Ku, Japan
  • Nobuhisa Nao-i
    Ophthalmology, Miyazaki Univ, School of Med, Kiyotake, Japan
  • Yuko Wada
    Wada Yuko Eye Clinic, Sendai, Japan
  • Yozo Miyake
    Ophthalmology, Nagoya Univ School of Medicine, Aichi gun, Japan
  • Yukihiko Mashima
    R-Tech Ueno, Tokyo, Japan
  • Footnotes
    Commercial Relationships  Shuichi Yamamoto, None; Takeshi Sugawara, None; Mitsuru Nakazawa, None; Shigeki Machida, None; Akira Murakami, None; Nobuhisa Nao-i, None; Yuko Wada, None; Yozo Miyake, None; Yukihiko Mashima, R-Tech Ueno (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 4992. doi:
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      Shuichi Yamamoto, Takeshi Sugawara, Mitsuru Nakazawa, Shigeki Machida, Akira Murakami, Nobuhisa Nao-i, Yuko Wada, Yozo Miyake, Yukihiko Mashima; Microperimetry Shows Protection of Central Vision in Retinitis Pigmentosa Patients treated with UF-021: a Phase 2 Study (JapicCTI-090748). Invest. Ophthalmol. Vis. Sci. 2011;52(14):4992.

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

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Abstract

Purpose: : To test the dose-dependent effects of UF-021 in protecting and improving the central vision in mid- to late-stage retinitis pigmentosa (RP) patients.

Methods: : The safety and efficacy were evaluated by randomized, double-masked parallel 3-arm comparative study of UF-021 in 0.15% ophthalmic solution. One hundred and nine eyes of 112 mid- to late-stage RP patients with visual acuity of 0.5 or better were evaluated at 6 centers with placebo or 1 drop or 2 drops of UF-021 twice daily for 24 weeks. The primary endpoint was a change in the retinal sensitivity from the baseline in the central 2 deg determined by Microperimeter-1 (MP-1). The background luminance of MP-1 was 4 asb and provided mesopic retinal sensitivity. The secondary endpoints were changes from the baseline of the visual acuity (ETDRS), contrast sensitivity, retinal sensitivity within the central 10 deg by MP-1, MD and retinal sensitivity within the central 2 deg by Humphrey perimetry 10-2, and the VFQ-25 questionnaire.

Results: : The slope test by simple linear regression analysis showed positive dose-responsiveness for changes of retinal sensitivity of the central 2 deg by MP-1 in the 3 arms (P=0.038) after adjustment for baseline differences. There were statistically significant differences between the placebo and high-dose groups in the change of retinal sensitivity from the baseline (placebo -0.13 dB, high dose 1.11 dB; P=0.038) and in the proportion of patients with worsening of the retinal sensitivity by≥4 dB (placebo 21.2%, high dose 2.6%; P=0.02). There was no significant dose-responsiveness in the changes of the retinal sensitivity by MP-1 central 10 deg. No serious adverse reactions were observed.

Conclusions: : The high dose (2 drops) treatment prevented the deterioration of central 2-degree retinal sensitivity in mid- to late-stage of RP patients and was safe. These data support further clinical development of UF-021.

Clinical Trial: : http://www.clinicaltrials.jp, JapicCTI-090748

Keywords: retinal degenerations: hereditary • neuroprotection 
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