Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study.
OBJECTIVE
To determine the impact of ranibizumab 0.5 mg on patient-reported visual function over 36 months in individuals with visual impairment from diabetic macular edema.


METHODS
RESTORE comprises a phase 3, randomized, multicenter, 12 month core study and a 24 month open-label extension study. Eyes assigned to ranibizumab in the core study received ranibizumab for 36 months; eyes assigned to laser monotherapy in the core study received ranibizumab during the extension. The primary outcome was least-squares mean change in National Eye Institute 25-item Visual Functioning Questionnaire (NEI VFQ-25) overall composite and subscale scores.


RESULTS
Of 303 core study participants, 240 (79%) entered the extension, comprising 83 (35%) participants initially assigned to ranibizumab, 83 (35%) assigned to ranibizumab plus laser combination therapy, and 74 (31%) assigned to laser monotherapy. Least-squares mean (standard error) change in NEI VFQ-25 composite score from baseline to month 12 (+5.9 [1.5]; +5.0 [1.5], for the ranibizumab and combination therapy groups, respectively) decreased by month 36 (+4.1 [1.7]; +4.0 [1.7], respectively, from baseline to month 36) following reduced injection frequency relative to the core study. At 36 months, the least-squares mean (standard error) change in the laser monotherapy group was similar to that in the ranibizumab groups (+4.1 [1.8]). Most subscale scores showed outcomes similar to that for the composite score. The greatest NEI VFQ-25 gains were consistently observed in participants for whom the study eye was the better-seeing eye.


CONCLUSIONS
Patients entering the extension were not randomized, and 21% of the core study participants did not enter the extension, which may have affected the results.


CONCLUSIONS
Gains in patient-reported visual function at month 12 among eyes receiving ranibizumab in the core study decreased slightly by 36 months. Eyes originally receiving laser monotherapy for 12 months then ranibizumab for 24 months achieved similar gains by 36 months to eyes receiving ranibizumab for 36 months.


BACKGROUND
ClinicalTrials.gov: NCT00687804 and NCT00906464.
a a Department of Ophthalmology and Westmead Millennium Institute , University of Sydney , Sydney , Australia.
Paul
P
Mitchell
b b Service d'Ophtalmologie, Hôpital Lariboisière APHP, Université Paris Diderot , Paris , France.
Pascale
P
Massin
c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.
Susan
S
Bressler
d d Outcometrix , Tucson , AZ , USA.
Cheryl D
CD
Coon
e e Novartis Pharma AG , Basel , Switzerland.
Jennifer
J
Petrillo
e e Novartis Pharma AG , Basel , Switzerland.
Alberto
A
Ferreira
c c Retina Division , Wilmer Eye Institute, Johns Hopkins University School of Medicine , Baltimore , MD , USA.
Neil M
NM
Bressler
D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003930:Diabetic Retinopathy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008269:Macular Edema / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D014792:Visual Acuity
D020533:Angiogenesis Inhibitors; D000069579:Ranibizumab
Diabetic retinopathy; Macular edema; Ranibizumab; Retina