PMID- 28715589
OWN - NLM
STAT- MEDLINE
DCOM- 20170728
LR  - 20180216
IS  - 1552-5783 (Electronic)
IS  - 0146-0404 (Linking)
VI  - 58
IP  - 9
DP  - 2017 Jul 1
TI  - Association Between Visual Function Response and Reduction of Inflammation in 
      Noninfectious Uveitis of the Posterior Segment.
PG  - 3555-3562
LID - 10.1167/iovs.17-22049 [doi]
AB  - PURPOSE: To examine the association between visual function response (VFR) and 
      inflammation reduction in active noninfectious uveitis of the posterior segment 
      (NIU-PS). METHODS: Phase 3 SAKURA Study 1 randomized 347 subjects in a 
      double-masked fashion to receive injections of intravitreal sirolimus 44 mug (n = 
      117); 440 mug (n = 114); or 880 mug (n = 116) every other month. Vitreous haze (VH) 
      response, a measure of inflammation reduction, was defined as a VH score of 0 or 
      0.5+ at month 5 based on the modified Standardized Uveitis Nomenclature Scale. 
      Visual function was assessed with best-corrected visual acuity (BCVA) and the 
      National Eye Institute (NEI) Visual Function Questionnaire-25 (VFQ-25). In this 
      post-hoc analysis, principal component analysis was used to reduce the 
      information in the multidimensional visual function outcome to a restricted 
      number of independently relevant VFR measures. Minimal clinically important 
      differences (MCID) for the VFQ-25-derived components were based on the standard 
      error of measurements. Overall VFR was defined as either a BCVA improvement of >/=2 
      lines, or an improvement exceeding the MCID in the VFQ-25 based visual function 
      measures. RESULTS: The VFQ-25 composite score (VFQCS) and mental health subscale 
      score (VFQMHS) were retained as relevant VFRs, with MCIDs of 4.3 and 11.7 points, 
      respectively. A vitreous haze response was significantly associated with each VFR 
      measure: VFQCS (odds ratio [OR] = 2.23; P = 0.0004); VFQMHS (OR = 2.84; P < 
      0.0001); BCVA (OR = 2.60; P = 0.0009), and overall VFR (OR = 2.65; P < 0.0001). 
      CONCLUSIONS: Inflammation reduction to a VH score of 0 or 0.5+ was significantly 
      associated with improved visual function. Achieving a VH response of 0 or 0.5+ is 
      a patient-relevant outcome.
FAU - Lescrauwaet, Benedicte
AU  - Lescrauwaet B
AD  - Xintera Ltd, Cambridge, United Kingdom.
FAU - Miserocchi, Elisabetta
AU  - Miserocchi E
AD  - San Raffaele Scientific Institute, Milan, Italy.
FAU - Thurau, Stephan
AU  - Thurau S
AD  - Ludwig-Maximilians-Universitat Munchen, Munich, Germany.
FAU - Bodaghi, Bahram
AU  - Bodaghi B
AD  - La Pitie-Salpetriere University Hospital, Paris, France.
FAU - Duchateau, Luc
AU  - Duchateau L
AD  - Ghent University, Ghent, Belgium.
FAU - Verstraeten, Thomas
AU  - Verstraeten T
AD  - P-95, Leuven, Belgium.
FAU - Srivastava, Sunil
AU  - Srivastava S
AD  - Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Invest Ophthalmol Vis Sci
JT  - Investigative ophthalmology & visual science
JID - 7703701
RN  - 0 (Immunosuppressive Agents)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Double-Blind Method
MH  - Eye Infections/physiopathology
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/*therapeutic use
MH  - Inflammation/*drug therapy/physiopathology
MH  - Intravitreal Injections
MH  - Male
MH  - Middle Aged
MH  - Patient Reported Outcome Measures
MH  - Sickness Impact Profile
MH  - Sirolimus/administration & dosage/*therapeutic use
MH  - Surveys and Questionnaires
MH  - Uveitis, Posterior/*drug therapy/physiopathology
MH  - Visual Acuity/*physiology
MH  - Vitreous Body/pathology
EDAT- 2017/07/18 06:00
MHDA- 2017/07/29 06:00
CRDT- 2017/07/18 06:00
PHST- 2017/07/18 06:00 [entrez]
PHST- 2017/07/18 06:00 [pubmed]
PHST- 2017/07/29 06:00 [medline]
AID - 2644721 [pii]
AID - 10.1167/iovs.17-22049 [doi]
PST - ppublish
SO  - Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3555-3562. doi: 
      10.1167/iovs.17-22049.