Patient-Reported Visual Function Outcomes Improve After Ranibizumab Treatment in Patients With Vision Impairment Due to Diabetic Macular Edema

Abstract

for the RESTORE Study Group 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 (RESTORE).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 or 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 at 0, 3, and 12 months for patients receiving 1 or more study treatments with 1 or more postbaseline NEI VFQ-25 assessments and last observation carried forward for missing data.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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00687804

Changes in vision related quality of life in patients with diabetic macular edema: Ranibizumab or laser treatment?

“…The RESTORE trial (Mitchell et al, 2013) is the first to assess the impact of ranibizumab treatment on health related quality of life (HR-QoL) using the VFQ-25. In this study, treatment with ranibizumab as monotherapy and combined with laser treatment is superior to laser treatment in rapidly improving and sustaining visual acuity, CRT and HRQoL in patients with DME, similar with our study.…”

“…The mean change in VFQ-25 composite scores was significant with ranibizumab monotherapy and combined with laser (5.0 and 5.4 point) versus laser. The highest HR-QoL benefit for ranibizumab compared with laser alone was observed for general vision, near, and distance activities in VFQ-25 subscales (Mitchell et al, 2011(Mitchell et al, , 2013. Bressler et al (2014) determined the effects of IVR treatment on patient's VFQ-25 scores, with visual impairment secondary to DME (382 RIDE patients and 377 RISE patients).…”

“…Recently, the RISE and RIDE Phase III studies have clearly demonstrated the beneficial effect of intravitreal injection of ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA), a humanized monoclonal antibody fragment that binds all active forms of VEGF-A, for patients with CSME (Bressler et al, 2014). Previous studies reported that IVR was more effective in improvements of visual acuity, central retinal thickness than the laser treatment in CSME (Bressler et al, 2014;Ip, Domalpally, Sun, & Ehrlich, 2014;Mitchell et al, 2011Mitchell et al, , 2013.…”

Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial

“…These results differ from studies of anti-vascular endothelial growth factor treatment for DME, which have reported better patient-centered outcomes than no treatment or macular laser treatment. 7,8 The UAB-LLQ outcomes were similar to the NEI VFQ-25 outcomes, which might be expected since the composite score and certain subscales evaluate similar domains of visual function, even though the UAB-LLQ was designed for studying patients with age-related macular degeneration. 3 No meaningful differences in the peripheral vision subscales from the NEI VFQ-25 or UAB-LLQ were identified, even though Humphrey Visual Field testing, an objective measure of peripheral vision, identified substantial differences in visual fields at the 1-year visit, which persisted through the 2-year visit.…”

“…[7][8][9][10] A second post-hoc subgroup analysis was conducted to determine if the treatment effect differed by whether the study eye had DME at baseline for which ranibizumab was required by protocol in both groups (based on gender-and machinespecific thresholds of retinal thickness and visual acuity impairment of 20/32 or worse).…”