Diabetic Population-Based Model to Estimate Impact of Ranibizumab on Diabetic Retinopathy Severity in Patients with Diabetic Macular Edema
Open Access
- 1 May 2020
- journal article
- research article
- Published by Taylor & Francis Ltd in Clinical Ophthalmology
- Vol. ume 14, 1249-1259
- https://doi.org/10.2147/opth.s236636
Abstract
Purpose: Estimate effects of ranibizumab on diabetic retinopathy (DR) severity in US Hispanic and non-Hispanic white persons with center-involved diabetic macular edema (DME) causing vision impairment for whom ranibizumab treatment would be considered. Patients and Methods: This model simulated DR severity outcomes over 2 years in the better-seeing eye using US census, National Health and Nutrition Examination Survey, Wisconsin Epidemiologic Study of Diabetic Retinopathy, and Los Angeles Latino Eye Study data. Baseline DR severity estimated from Diabetic Retinopathy Clinical Research Network trial data. Changes in DR severity after 2 years, with/without monthly ranibizumab (0.3 or 0.5 mg), were estimated from Phase III clinical trial data (RIDE/RISE) using a 2-dimensional Monte Carlo simulation model. Number of patients over a 2-year period for whom 1) DR severity worsening was avoided, 2) DR severity improved, and 3) selected clinical events related to proliferative DR (PDR) occurred, was estimated. Results: An estimated 37,274 US Hispanic and non-Hispanic white persons were projected to have DR with center-involved DME and be eligible for ranibizumab treatment. The number of persons with moderately severe non-proliferative DR (NPDR) or less severe DR at baseline who would worsen to PDR and experience a PDR complication over 2 years would be reduced from 437 with no ranibizumab to 19 with ranibizumab (95% reduction; 95% simulation interval [SI], 79– 100%). The number of persons with severe NPDR or less severe DR at baseline who would be expected to improve by ≥ 2 DR severity levels over 2 years would increase from 1706 with no ranibizumab to 13,042 with ranibizumab (682% increase; 95% SI, 478– 967%). Conclusion: This model estimates that ranibizumab treatment in US Hispanic and non-Hispanic white patients with center-involved DME causing vision impairment would potentially reduce the number of patients with worsening DR and potentially increase the number with DR improvements.Keywords
This publication has 30 references indexed in Scilit:
- Electroretinographic findings associated with panretinal photocoagulation (PRP) versus PRP plus intravitreal ranibizumab treatment for high-risk proliferative diabetic retinopathyDocumenta Ophthalmologica, 2012
- Global Prevalence and Major Risk Factors of Diabetic RetinopathyDiabetes Care, 2012
- Severity of Diabetic Retinopathy and Health-Related Quality of Life: The Los Angeles Latino Eye StudyOphthalmology, 2011
- Prevalence of Diabetic Retinopathy in the United States, 2005-2008JAMA, 2010
- Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular EdemaOphthalmology, 2010
- Four-Year Incidence and Progression of Diabetic Retinopathy and Macular Edema: The Los Angeles Latino Eye StudyAmerican Journal of Ophthalmology, 2010
- Burden of illness of diabetic macular edema: literature reviewCurrent Medical Research and Opinion, 2010
- Overview of Epidemiologic Studies of Diabetic RetinopathyOphthalmic Epidemiology, 2007
- Diabetic Retinopathy in a Multi-ethnic Cohort in the United StatesAmerican Journal of Ophthalmology, 2006
- The impact of diabetic retinopathy: perspectives from patient focus groupsFamily Practice, 2004