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Akira Hagiwara, Takeshi Sugawara, ken kumagai, Ryuta Kimoto, Shuichi Yamamoto; Change in Visual Function after UF-021 Therapy for Retinitis Pigmentosa. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4581.
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We have reported that topical 0.15% unoprostone ophthalmic solution, UF-021, results in a dose-dependent improvement in the central retinal sensitivity in patients with retinitis pigmentosa (RP). The purpose of this study was to determine whether the changes in the retinal sensitivity were maintained for the 48 months after the end of the UF-021 trial.
We studied 22 RP patients who had been part of the origin 24-week clinical trial of UF-021. These patients had been randomly assigned to one of the three double-blind treatments: high dose (H, two drops/dose; n=6), low dose (L, one drop/dose; n=8), and placebo (P, n=8). The therapy was terminated in all the patients after the 24 week clinical trial. We examined the mean retinal sensitivity of four central points using the Humphrey Field Analyzer (HFA) 10-2 program, mean deviation (MD value), and BCVA at the start and end of the clinical trial, and at 48 weeks after completion of the trial.
At 48 weeks after the completion of the clinical trial, the sensitivity of the four central points and the mean change (dB) of the MD values were 1.52 ± 2.33 dB and -0.11 ± 1.17 dB for the H group, -2.05 ± 3.77 dB and -1.54 ± 3.04 dB for the L group, and 0.11 ± 4.18 dB and -0.61 ± 2.55 dB for the P group. These findings indicated a worsening of the retinal sensitivity after the termination of UF-021 therapy. In the H group, however, the degree of worsening was small, and the disease progression compared with the P group was slowed by the therapy from the start through the 72 weeks. However, the difference in the slowing between these two groups was not significant. No significant changes were observed in the final BCVA.
The H group tended to have a slowing of the disease progression even after UF-021 therapy was stopped suggesting a long-term maintenance of visual sensitivity by UF-021.
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