TY - JOUR
T1 - Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema randomized clinical trial
AU - Mitchell, Paul
AU - Bressler, Neil
AU - Tolley, Keith
AU - Gallagher, Meghan
AU - Petrillo, Jennifer
AU - Ferreira, Alberto
AU - Bandello, Francesco
PY - 2013/10
Y1 - 2013/10
N2 - Importance Few data are available on relative changes in vision-related function after treatment for diabetic macular edema (DME). Objective To determine the impact of intravitreal ranibizumab, 0.5 mg, compared with laser on patient-reported visual function. DESIGN Phase 3, randomized, double-masked, 12-month study. Setting Outpatient retina practices in Australia, Canada, and Europe. PARTICIPANTS Patients 18 years or older with type 1 or 2 diabetes mellitus and visual impairment due to DME. Interventions Patients were randomized to ranibizumab plus sham laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus laser (n = 111). Ranibizumab and sham injections were given for 3 consecutive months then as needed; laser plus sham laser treatment was given at baseline then as needed. Main Outcomes And Measures National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) scores at0, 3, and 12 months for patients receiving 1 or more study treatments with 1 ormorepostbaselineNEIVFQ- 25assessmentsandlastobservationcarriedforwardformissingdata. Results Mean baseline NEI VFQ-25 composite scores were 72.8, 73.5, and 74.1 in the ranibizumab, laser, and ranibizumab plus laser groups, respectively. At 12 months, the mean composite scores (95%CIs) improved by 5.0 (ranibizumab vs laser, 2.6 to 7.4; P =.01 vs laser) and 5.4 (ranibizumab plus laser vs laser alone, 3.3 to 7.4; P =.004 vs laser) from baseline in the ranibizumab and ranibizumab plus laser groups, respectively, compared with 0.6 (-1.8 to 3.0) for the laser group. Near activities scores improved by 9.0 (ranibizumab vs laser, 5.0 to 13.0; P =.01) and 9.1 (ranibizumab plus laser vs laser, 5.6 to 12.6; P =.006) compared with 1.1 (-3.0 to 5.2) for the laser group, whereas distance activities scores improved by 5.3 (ranibizumab vs laser, 1.8 to 8.9; P =.04) and 5.6 (ranibizumab plus laser vs laser, 2.3 to 9.0; P =.03) compared with 0.4 (-3.1 to 3.8) for the laser group. Patients with better baseline visual acuity or lower central retinal thickness had greater improvements with ranibizumab treatment compared with laser in composite and some subscale scores compared with patients with worse visual acuity or higher central retinal thickness. CONCLUSIONS AND RELEVANCE These data provide vision-related, patient-reported outcome evidence that mirrors visual acuity outcomes and supports benefits from ranibizumab or ranibizumab plus laser treatment for patients with DME and characteristics similar to those enrolled in this randomized clinical trial.
AB - Importance Few data are available on relative changes in vision-related function after treatment for diabetic macular edema (DME). Objective To determine the impact of intravitreal ranibizumab, 0.5 mg, compared with laser on patient-reported visual function. DESIGN Phase 3, randomized, double-masked, 12-month study. Setting Outpatient retina practices in Australia, Canada, and Europe. PARTICIPANTS Patients 18 years or older with type 1 or 2 diabetes mellitus and visual impairment due to DME. Interventions Patients were randomized to ranibizumab plus sham laser (n = 116), ranibizumab plus laser (n = 118), or sham injections plus laser (n = 111). Ranibizumab and sham injections were given for 3 consecutive months then as needed; laser plus sham laser treatment was given at baseline then as needed. Main Outcomes And Measures National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) scores at0, 3, and 12 months for patients receiving 1 or more study treatments with 1 ormorepostbaselineNEIVFQ- 25assessmentsandlastobservationcarriedforwardformissingdata. Results Mean baseline NEI VFQ-25 composite scores were 72.8, 73.5, and 74.1 in the ranibizumab, laser, and ranibizumab plus laser groups, respectively. At 12 months, the mean composite scores (95%CIs) improved by 5.0 (ranibizumab vs laser, 2.6 to 7.4; P =.01 vs laser) and 5.4 (ranibizumab plus laser vs laser alone, 3.3 to 7.4; P =.004 vs laser) from baseline in the ranibizumab and ranibizumab plus laser groups, respectively, compared with 0.6 (-1.8 to 3.0) for the laser group. Near activities scores improved by 9.0 (ranibizumab vs laser, 5.0 to 13.0; P =.01) and 9.1 (ranibizumab plus laser vs laser, 5.6 to 12.6; P =.006) compared with 1.1 (-3.0 to 5.2) for the laser group, whereas distance activities scores improved by 5.3 (ranibizumab vs laser, 1.8 to 8.9; P =.04) and 5.6 (ranibizumab plus laser vs laser, 2.3 to 9.0; P =.03) compared with 0.4 (-3.1 to 3.8) for the laser group. Patients with better baseline visual acuity or lower central retinal thickness had greater improvements with ranibizumab treatment compared with laser in composite and some subscale scores compared with patients with worse visual acuity or higher central retinal thickness. CONCLUSIONS AND RELEVANCE These data provide vision-related, patient-reported outcome evidence that mirrors visual acuity outcomes and supports benefits from ranibizumab or ranibizumab plus laser treatment for patients with DME and characteristics similar to those enrolled in this randomized clinical trial.
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U2 - 10.1001/jamaophthalmol.2013.4592
DO - 10.1001/jamaophthalmol.2013.4592
M3 - Article
C2 - 23974915
AN - SCOPUS:84885933408
SN - 2168-6165
VL - 131
SP - 1339
EP - 1347
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
IS - 10
ER -