Visual Impairment and Blindness Avoided with Ranibizumab in Hispanic and Non-Hispanic Whites with Diabetic Macular Edema in the United States

• Published in: Ophthalmology (Rochester, Minn.) Vol. 122; no. 5; pp. 982 - 989
• Main Authors: Varma, Rohit, MD, MPH, Bressler, Neil M., MD, Doan, Quan V., PharmD, Danese, Mark, PhD, Dolan, Chantal M., PhD, Lee, Abraham, BA, Turpcu, Adam, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2015
• Subjects: Aged; Aged, 80 and over; Angiogenesis Inhibitors - therapeutic use; Antibodies, Monoclonal, Humanized - therapeutic use; Blindness - ethnology; Blindness - prevention & control; Diabetic Retinopathy - drug therapy; Diabetic Retinopathy - ethnology; European Continental Ancestry Group - ethnology; Female; Hispanic Americans - ethnology; Humans; Intravitreal Injections; Macular Edema - drug therapy; Macular Edema - ethnology; Male; Middle Aged; Models, Statistical; Ophthalmology; Ranibizumab; United States - epidemiology; Vascular Endothelial Growth Factor A - antagonists & inhibitors; Vision, Low - ethnology; Vision, Low - prevention & control; Visual Acuity - physiology; Visually Impaired Persons - statistics & numerical data; United States; A Study of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema (ME) with Center Involvement Secondary to Diabetes Mellitus; VEGF; simulation interval; LALES; visual acuity; VA; Diabetic Retinopathy Clinical Research; RISE; BCVA; VI; SI; vascular endothelial growth factor; best-corrected visual acuity; Los Angeles Latino Eye Study; AMD; visual impairment; age-related macular degeneration; DRCR; DME; RIDE; diabetic macular edema
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2014.12.007

Objective To estimate visual impairment (VI) and blindness avoided with intravitreal ranibizumab 0.3 mg treatment for central-involved diabetic macular edema (DME) among Hispanic and non-Hispanic white individuals in the United States. Design Population-based model simulating visual acuity (VA) outcomes over 2 years after diagnosis and treatment of DME. Participants Visual acuity changes with and without ranibizumab were based on data from the RISE, RIDE, and DRCR Network trials. Methods For the better-seeing eye, VA outcomes included VI, defined as worse than 20/40 in the better-seeing eye, and blindness, defined as VA of 20/200 or worse in the better-seeing eye. Incidence of 1 or both eyes with central-involved DME in 2010 were estimated based on the 2010 United States population, prevalence of diabetes mellitus, and 1-year central-involved DME incidence rate. Sixty-one percent of incident individuals had bilateral DME and 39% had unilateral DME, but DME could develop in the fellow eye. Main Outcomes Measures Cases of VI and blindness avoided with ranibizumab treatment. Results Among approximately 102 million Hispanic and non-Hispanic white individuals in the United States 45 years of age and older in 2010, an estimated 37 274 had central-involved DME and VI eligible for ranibizumab treatment. Compared with no ranibizumab treatment, the model predicted that ranibizumab 0.3 mg every 4 weeks would reduce the number of individuals with VI from 11 438 (95% simulation interval [SI], 7249–16 077) to 6304 (95% SI, 3921–8981), a 45% (95% SI, 36%–53%) reduction at 2 years. Ranibizumab would reduce the number of incident eyes with VA worse than 20/40 from 16 910 (95% SI, 10 729–23 577) to 9361 (95% SI, 5839–13 245), a 45% (95% SI, 38%–51%) reduction. Ranibizumab was estimated to reduce the number of individuals with legal blindness by 75% (95% SI, 58%–88%) and the number of incident eyes with VA of 20/200 or worse by 76% (95% SI, 63%–87%). Conclusions This model suggests that ranibizumab 0.3 mg every 4 weeks substantially reduces prevalence of VI and legal blindness 2 years after initiating treatment among Hispanic and non-Hispanic white individuals in the United States with central-involved DME that has caused vision loss.