Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE

• Published in: Ophthalmology (Rochester, Minn.) Vol. 121; no. 12; pp. 2461 - 2472
• Main Authors: Bressler, Neil M, Varma, Rohit, Suñer, Ivan J, Dolan, Chantal M, Ward, James, Ehrlich, Jason S, Colman, Shoshana, Turpcu, Adam
• Format: Journal Article
• Language: English
• Published: United States 01.12.2014
• Subjects: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors - therapeutic use; Antibodies, Monoclonal, Humanized - therapeutic use; Diabetic Retinopathy - drug therapy; Diabetic Retinopathy - physiopathology; Double-Blind Method; Female; Humans; Intravitreal Injections; Macular Edema - drug therapy; Macular Edema - physiopathology; Male; Middle Aged; Ranibizumab; Surveys and Questionnaires; Visual Acuity - physiology; Young Adult
• ISSN: 1549-4713
• DOI: 10.1016/j.ophtha.2014.07.008

To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as assessed by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores, in patients with visual impairment secondary to center-involved diabetic macular edema (DME). Within 2 randomized, double-masked, phase 3 clinical trials (RIDE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473382] and RISE [A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema {ME} With Center Involvement Secondary to Diabetes Mellitus; NCT00473330]), the NEI VFQ-25 was administered at baseline and at the 6-, 12-, 18-, and 24-month follow-up visits. Three hundred eighty-two (100%) RIDE patients and 377 (100%) RISE patients. Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham. Study participants could receive macular laser for DME from month 3 onward if specific criteria were met. Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months. Across all treatment arms, 13% to 28% of enrolled eyes were the better-seeing eye. For all eyes in RIDE and RISE, the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12- and 24-month visits compared with sham treatment. For the better-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more (95% confidence interval [CI], 2.5-19.2) than sham for RIDE patients and 1.3 more (95% CI, -10.5 to 13.0) than sham for RISE patients. For the worse-seeing eyes at baseline, the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more (95% CI, -4.7 to 6.7) than sham for RIDE patients and 1.8 more (95% CI, -2.7 to 6.2) than sham for RISE patients. Similar results for most of these outcomes were seen with 0.5 mg ranibizumab. These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham, further supporting treatment of DME with ranibizumab.