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Erin Vigil, Yasir Sepah, Owhofasa Agbedia, Anthony Watters, Mohammad sadiq, Mehreen Ansari, Millena Bittencourt, Mohamed Ibrahim, Quan Dong Nguyen; Assessment of Changes in Quality of Life Among Patients in the SAVE Study - Sirolimus As Therapeutic Approach To UVEItis: A Randomized Study To Assess The Safety And Bioactivity Of Intravitreal And Subconjunctival Injections Of Sirolimus In Patients With Non-infectious Uveitis. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5391. doi: https://doi.org/.
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To assess the change in quality of life (QOL) in patients with non-infectious posterior, intermediate, or panuveitis, treated with subconjunctival (SCJ) or intravitreal (IVT) sirolimus as an immunomodulatory therapeutic (IMT) agent, delivered subconjunctivally (SCJ) or intravitreally (IVT) (the SAVE Study).
The 25-question Visual Function questionnaire (VFQ-25) was administered at baseline, month 6, and month 12 visits. The survey measures self-reported vision health status for patients with chronic eye disease. The questionnaire assesses the effects of visual impairment on both task-oriented visual function and general health domains such as emotional well-being and social functioning. Each patient’s questionnaire was converted to a scaled score between 0 (worst) and 100 (best). Individual question scores were combined into 12 different subcategories.
Thirty subjects were randomized in the SAVE study (SCJ:IVT, 1:1). Among the 24 subjects who finished month 12, 18 completed all questions of the VFQ-25 at all three time points. Mean and median scores were calculated for each of the subcategories and for overall composite score at baseline, month 6, and month 12, using Stata 12 (Table 1). Wilcoxon signed-rank test was performed. Overall, patients showed a significant improvement in composite scores between BL and month 6 as well as BL and month 12. From BL to month 6, patients showed significant improvements in the subcategories of general vision, distance activities, vision-specific mental health, and vision-specific role difficulties. From BL to month 12,patients improved significantly in the subcategories of vision specific mental health and vision-specific role difficulties.
Patients with uveitis who have been treated with local delivery of sirolimus demonstrated significant improvement in their QOL during the 12-month course of therapy. Specifically, subjects have gained in vision health and function. Larger randomized control trials with sirolimus are indicated to validate this gain in QOL.
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