Randomized, double-blind, placebo-controlled clinical trial on the efficacy of
0.5% indomethacin eye drops in uveitic macular edema.
Author(s): Allegri P(1), Murialdo U, Peri S, Carniglia R, Crivelli MG, Compiano S, Autuori
S, Mastromarino A, Zurria M, Marrazzo G.
Affiliation(s): Author information:
(1)Ophthalmology Department, Uveitis Tertiary Referral Center, Rapallo Hospital,
Genova, Italy.
Publication date & source: 2014, Invest Ophthalmol Vis Sci. , 55(3):1463-70
PURPOSE: The aim of the present randomized, double-blind, placebo-controlled
clinical trial was to assess the efficacy and tolerability of 0.5% indomethacin
(INDOM) eye drops in adult patients suffering from macular edema (ME) related to
different etiology uveitis.
METHODS: Forty-six eyes of 31 adult patients (20 females and 11 males) mean age
39 years, affected by inflammatory ME, were randomized to receive a dose of
commercial 0.5% INDOM eye-drops four times per day (16 subjects = 23 eyes) or
placebo (the vehicle of INDOM, 15 subjects = 23 eyes) during a 6-month active
therapy follow-up. Study assessment at each visit included visual acuity testing
(VA), slit-lamp examination, IOP evaluation, and Heidelberg Spectralis optical
coherence tomography (OCT) central foveal thickness (CFT) measurement. Any
variation in subjective symptoms and tolerability was also detected.
RESULTS: Statistical analysis showed, from baseline to the 6-month visit, a
significant reduction in CFT (P < 0.0001) and a significant improvement in VA
only in the 0.5% INDOM-treated group; a global reduction of discomfort symptoms
was present in both groups (P < 0.001).
CONCLUSIONS: The four times per day administration of 0.5% INDOM eye drops in
eyes affected with uveitic ME from different etiologies, compared with placebo,
is associated with a significant reduction in ME at the 6-month follow-up visit,
as measured by spectral-domain optical coherence tomography (SD-OCT). However,
not all eyes showed a complete resolution of ME because of vitreoretinal
traction. (https://eudract.ema.europa.eu/index.html number, EUDRACT
2011-001522-20.).
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