Purchase this article with an account.
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.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
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.
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.
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.
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: :
This PDF is available to Subscribers Only