RESPONSIVENESS OF THE NATIONAL EYE INSTITUTE VISUAL FUNCTION QUESTIONNAIRE-25 TO VISUAL ACUITY GAINS IN PATIENTS WITH DIABETIC MACULAR EDEMA: Evidence From the RIDE and RISE Trials.
OBJECTIVE
To evaluate the responsiveness of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in patients with diabetic macular edema using data from the RIDE and RISE trials.


METHODS
Patients were randomized to monthly intravitreal ranibizumab 0.3 mg, 0.5 mg, or sham injections for 2 years. The NEI VFQ-25 was administered at baseline and at Months 6, 12, 18, and 24. The least-squares mean change in NEI VFQ-25 for ≥15 letters gained or lost was derived from analysis of covariance models.


RESULTS
The mean improvement in NEI VFQ-25 composite score associated with a ≥15-letter gain in best-corrected visual acuity over 24 months was 9.0 (95% confidence interval, 6.3-11.7) points in RIDE and 7.1 (95% confidence interval, 4.7-9.6) points in RISE. In patients who lost ≥15 letters, the mean worsening in overall NEI VFQ-25 composite score was -6.6 (95% confidence interval, -13.6 to 0.5) in RIDE and -2.7 (95% confidence interval, -8.9 to 3.5) in RISE.


CONCLUSIONS
This exploratory analysis of data from the RIDE and RISE studies supports the responsiveness of the NEI VFQ-25 to changes in best-corrected visual acuity over time in patients with diabetic macular edema.
*Retina Associates of Florida, P.A., Tampa, Florida; †Johns Hopkins University, Baltimore, Maryland; ‡USC Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, California; and §Genentech, Inc, South San Francisco, California.
Ivan J
IJ
Suñer
Neil M
NM
Bressler
Rohit
R
Varma
Chantal M
CM
Dolan
James
J
Ward
Adam
A
Turpcu
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D003930:Diabetic Retinopathy / Q000150:complications / Q000188:drug therapy / Q000503:physiopathology*; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology*; D008297:Male; D008875:Middle Aged; D054554:National Eye Institute (U.S.); D000069579:Ranibizumab / Q000008:administration & dosage*; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D014481:United States; D014792:Visual Acuity
D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab
Br J Ophthalmol. 2008 Jan;92(1):89-92
17584999
Ophthalmology. 2014 Dec;121(12):2461-72
25148789
Arch Ophthalmol. 2001 Jul;119(7):1050-8
11448327
Ophthalmology. 2010 Apr;117(4):747-56.e4
20189654
Ophthalmology. 2011 Apr;118(4):615-25
21459215
Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10 ):7498-505
21896838
Arch Ophthalmol. 2005 Sep;123(9):1207-14
16157800
Arch Ophthalmol. 2003 Sep;121(9):1297-302
12963613
Ophthalmology. 2010 Apr;117(4):757-65
20122736
Arch Ophthalmol. 2007 Nov;125(11):1460-9
17998507
Ophthalmology. 2012 Apr;119(4):789-801
22330964
Ophthalmology. 1996 Jan;103(1):181-2
8628551
Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):205-15
17896299
Invest Ophthalmol Vis Sci. 2011 May 18;52(6):3354-9
21282568
Diabetes Care. 2003 Sep;26(9):2653-64
12941734
Arch Ophthalmol. 2004 May;122(5):758-66
15136325
Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35
19255158
Arch Ophthalmol. 1998 Nov;116(11):1496-504
9823352
Arch Ophthalmol. 2009 Jan;127(1):13-21
19139332
Invest Ophthalmol Vis Sci. 2008 Feb;49(2):479-89
18234989
Acta Diabetol. 2013 Dec;50(6):873-7
23526056
JAMA Ophthalmol. 2013 Oct;131(10):1339-47
23974915