Abstract | INTRODUCTION: METHODS: A randomized, double-blind, and placebo-controlled phase II safety/efficacy trial was conducted. One hundred and nine patients with middle- to late-stage RP having a visual acuity of ≥0.5 were studied at six ophthalmological centers in Japan. The treatments of IU/day were divided into three groups: placebo group; two-drop group; and four-drop group for 24 weeks. The primary outcome measure was changes in the retinal sensitivity from baseline in the central 2° determined by MP-1 microperimetry (MP-1, Nidek, Japan). The secondary outcomes were changes in best-correct visual acuity, contrast sensitivity, retinal sensitivity of the central 10° by MP-1, mean deviation (MD) by a Humphrey field analyzer (HFA; Carl Zeiss Meditec, Dublin, CA, USA) 10-2, and the Visual Functioning Questionnaire 25 (VFQ-25) questionnaire scores. RESULTS: There was a tendency for a dose-dependent responsiveness in retinal sensitivity in the central 2°, MD, and total VFQ-25 score after 24 weeks of IU instillation by a simple linear regression analysis. A stratified analysis showed a significant dose-dependent responsiveness of the 2° central retinal sensitivity in more advanced patients (P = 0.028). The number of patients having a ≥4 dB decrease in the primary outcome measure was significantly fewer in the four-drop group than in the placebo group (P = 0.02). No adverse reactions were observed. CONCLUSIONS: A higher dose of IU can delay progression of the central retinal sensitivity decrease through an improvement of retinal sensitivity.
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Authors | Shuichi Yamamoto, Takeshi Sugawara, Akira Murakami, Mitsuru Nakazawa, Nobuhisa Nao-I, Shigeki Machida, Yuko Wada, Yukihiko Mashima, Yozo Myake |
Journal | Ophthalmology and therapy
(Ophthalmol Ther)
Vol. 1
Issue 1
Pg. 5
(12 2012)
ISSN: 2193-8245 [Print] England |
PMID | 25135585
(Publication Type: Journal Article)
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