Abstract
Purpose
To identify factors associated with visual outcomes in patients with diabetic macular edema (DME) treated with ranibizumab (RBZ) in the Ranibizumab for Edema of the mAcula in Diabetes—Protocol 2 (READ-2) Study.
Patients and methods
Optical coherence tomography scans, fundus photographs, and fluorescein angiograms (FAs) were graded and along with baseline characteristics were correlated with month (M) 24 visual outcome of best-corrected visual acuity (BCVA) ≤20/100 (poor outcome) vs >20/100 (better outcome).
Results
Of 101 patients with a M20 visit or beyond, 27 (27%) had BCVA ≤20/100. Comparison of patients with or without poor outcome showed mean baseline BCVA of 16.8 letters (20/125) in the former compared with 30.4 letters (20/63; P<0.001). Mean change in BCVA between baseline and M24 was −2.6 letters in the poor outcome group compared with +9.8 letters (P<0.001). Foveal thickness (FTH) at M24 was 374.1 μm in the poor outcome group compared with 268.8 μm (P<0.01), a difference driven by 14 patients with mean FTH of 450.3 μm. Foveal atrophy occurred in 65% (11/17) in the poor outcome group compared with 17%(12/71, P=0.001). Persistent edema was noted in 52% (14/27) of patients with poor outcome. Laser scars near foveal center were significantly more common in patients with poor outcome who did not have edema vs those who did (78% (7/9) vs 23% (3/13) P=0.03).
Conclusion
Poor baseline BCVA (≤20/125) in DME patients predicts poor visual outcome (≤20/100) after 2 years of treatment with RBZ and/or focal/grid laser, often due to foveal atrophy and/or persistent edema.
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
References
Klein R, Klein B . Vision disorders in diabetes. In: Group NDD editor, Diabetes in America 2nd ed. National Institutes of Health: Washington, DC, USA, 1995 pp 293–330.
Nguyen QD, Tatlipinar S, Shah SM, Haller JA, Quinlan E, Sung J et al. Vascular endothelial growth factor is a critical stimulus for diabetic macular edema. Am J Ophthalmol 2006; 142: 961–969.
Nguyen QD, Shah SM, Heier JS, Do DV, Lim J, Boyer D et al. Primary end point (six months) results of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) Study. Ophthalmology 2009; 116: 2175–2181.
Nguyen QD, Shah SM, Khwaja AA, Channa R, Hatef E, Do DV et al. Two-year outcomes of the Ranibizumab for Edema of the mAcula in Diabetes (READ-2) study. Ophthalmology 2010; 117: 2146–2151.
The Diabetic Retinopathy Clinical Research Network. Randomized trial evaluating ranibzumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmolgy 2010; 117: 1064–1077.
Massin P, Bandello F, Hansen LL, Harding SP, Larsen M, Mitchell P et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study). Diabetes Care 2010; 33: 2399–2405.
Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Masin P, Schlingemann RO et al. The RESTORE Study. Ranibizumab monotherapy or combined with laser vs laser monotherapy for diabetic macular edema. Ophthalmology 2011; 118: 615–625.
Nguyen QD, Brown DM, Marcus DM, Boyer DS, Patel S, Feiner L et al. Ranibizumab for diabetic macular edema. Results from 2 Phase III Randomized Trials: RISE and RIDE. Ophthalmology 2012; 119: 789–801.
Do DV, Nguyen QD, Khwaja AA, Channa R, Sepah YJ, Sophie R et al. Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment. JAMA Ophthalmol 2013; 131 (2): 139–145.
Chung EJ, Roh MI, Kwon OW, Koh HJ . Effects of macular ischemia on the outcome of intravitreal bevacizumab therapy for diabetic macular edema. Retina 2008; 28: 957–963.
Jonas JB, Martus P, Degenring RF, Kreissing I, Akkoyun I . Predictive factors for visual acuity after intravitreal triamcinolone treatment for diabetic macular edema. Arch Ophthalmol 2005; 123: 1338–1343.
Aiello LP, Edwards AR, Beck RW, Bressler NM, Davis MD, Ferris F et al. Factors associated with improvement and worsening of visual acuity 2 years after focal/grid photocoagulation for diabetic macular edema. Ophthalmology 2010; 117: 946–953.
Acknowledgements
Jiangxia Wang, MS, MA, assisted with the data analysis for this study. She is affiliated with the Biostatistics Center, Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health; supported by Wilmer Biostatistics Core Grant EY01765. The study was supported by Genentech and by a grant from the Juvenile Diabetes Research Foundation.
Author information
Authors and Affiliations
Consortia
Corresponding author
Ethics declarations
Competing interests
Afsheen Khwaja was an employee of JHU during the conduct of the study, but is now an employee of Santen Inc. Diana V Do has the following potential conflicts of interest: consultant for ISTA and Johns Hopkins University has received payment for her consulting with Regeneron and Genentech. She has received an honorarium from Heidelberg. Johns Hopkins University, the previous employer of Dr Do receives research support from Genentech, Regeneron, Heidelberg, and Pfizer. Quan Dong Nguyen has the following potential conflicts of interest: consultant for Bausch and Lomb, and Santen. The Johns Hopkins University receives payment for his consulting with Genentech, Acucela, Pfizer, Regeneron, GlaxoSmithKline, and Heidelberg. Johns Hopkins University, the previous employer of Dr Nguyen, has received research support from Genentech, MacuSight, and Regeneron. Dr Nguyen chairs the Steering Committee for the RISE and RIDE studies. Peter A Campochiaro has the following potential conflicts of interest: consultant for Kala Pharmaceuticals and Applied Genetic Technologies Corporation and served as a consultant for Allergan within the past 2 years. Johns Hopkins University receives payment for his consultation with Genentech, Regeneron, and Aerpio. He receives research support from Genentech, Regeneron, Allergan, Aerpio, Genzyme, and Oxford BioMedica. These activities are being managed by the Conflict of Interest Committee of the Johns Hopkins University School of Medicine.
Additional information
Contributors Clinical Sites Black Hills Regional Eye Institute: Principal Investigator: Prema Abraham, MD Coordinator: Buffi Green, Kristi Livermont East Bay Retina Consultants Principal Investigator: Eugene S Lit, MD Investigators: Daniel A Brinton, MD, Scott S Lee, MD Coordinator: Scotty Renslow Eye Care Specialists Principal Investigator: Erik F Kruger, MD Coordinator: Patty Yuhas, COA Illinois Retina Associates Principal Investigator: John S Pollack, MD Investigators: Joseph M. Civantos, MD Coordinator: Barbara J Ciscato Johns Hopkins University/Wilmer Eye Institute Principal Investigator: Diana V Do, MD Investigators: Peter Campochiaro, MD, Daniel Finkelstein, MD, Morton F Goldberg, MD, James T Handa, MD, Quan Dong Nguyen, MD, MSc, Jennifer U Sung, MD, Howard Ying, MD, PhD, Ingrid Zimmer-Galler, MD Coordinators: Gulnar Hafiz, MD, MPH, Lisa Azzaro, COT, Lisa Greer, COT, MBA, Ovais Shaikh, MD, COT, Jennifer Simmons, COT Midwest Eye Institute Principal Investigator: Thomas Ciulla, MD Coordinator: Neelam Thukral Ophthalmic Consultants of Boston Principal Investigator: Jeffrey S Heier, MD Investigators: Janet J Chieh, MD, Tina S Cleary, MD, Gregory L Fenton, MD, David S Liao, MD, Trexler M Topping, MD, Torsten W Wiegand, MD, Grant P Janzen, MD, Sumit P Shah, MD, Jeffrey A Chang, MD Coordinator: Lindsey Williams Retina Consultants of Arizona Principal Investigator: Pravin U Dugel, MD Investigators: Jack Sipperley, MD, Donald W Park, MD, Judy Liu, MD, Derek Y Kunimoto, MD, Edward J Quinlan, MD, Arthur Mollen, DO, Jaime R Gaitan, MD Coordinator: Sarah G Mobley, CCRC Retina Consultants of Nevada—Las Vegas Principal Investigator: Allen Thach, MD Investigators: Roger Simon, MD, R Jeffrey Parker, MD, Rodney D Hollifield, MD, Roy H Loo, MD, MeherYepremyan, MD, Irene Voo, MD, Jason C Wickens, MD Coordinators: Janet Seybert, Cassondra Major, Mia Davis, Christy Browder, Melissa Rediker Retina Institute of California Principal Investigator: Thomas S Chang, MD Investigators: Michael A Samuel, MD, Anthony J Culotta, MD, Ednan Ahmed, MD Coordinator: Yvette Baghoomian, Coleman Ho Retina-Vitreous Associates Medical Group Principal Investigator: David Boyer, MD Investigators: Roger L Novack, MD, PhD, Thomas G Chu, MD, PhD, Firas M Rahhal, MD, Janet Jill Hopkins, MD, FRCSC, HomayounTabandeh, MD, MS, FRCP, FRCS, FRCOphth, Richard H. Roe, MD, MHS Coordinator: Tammy Gasparyan, Janet Kurokouchi, Charles Yoon University of New Mexico Principal Investigator: Arup Das, MD, PhD Investigators: Mark Schluter, MD Coordinator: Sheila Nemeth, COMT University of Southern California/Doheny Eye Institute Principal Investigator: Jennifer Lim, MD (year 1); Dean Eliott, MD (years 2 and 3) Coordinator: Margaret Padilla Steering Committee Peter A Campochiaro, MD Jeffrey S Heier, MD Quan Dong Nguyen, MD, MSc, Chair Data Safety and Monitoring Committee Brian P Conway, MD, University of Virginia David Wilson, MD, Oregon Health and Science University, Casey Eye Institute Reading Center The Retinal Imaging Research and Reading Center at Wilmer Roomasa Channa, MD Mohamed Ibrahim, MD Yasir Sepah, MD Syed Mahmood Shah, MBBS. Data Collection and Monitoring Center, Wilmer Eye Institute, Johns Hopkins University Afsheen Khwaja, MD John Putzke, PhD, MSPH Yasir Sepah, MD Coordinating Center, Wilmer Eye Institute, Johns Hopkins University Gulnar Hafiz, MD, MPH Velma Pack, BA Statistical Analyses Raafay Sophie, MD Afsheen Khwaja, MD Roomasa Channa, MD Yasir Sepah, MD
Rights and permissions
About this article
Cite this article
Channa, R., Sophie, R., Khwaja, A. et al. Factors affecting visual outcomes in patients with diabetic macular edema treated with ranibizumab. Eye 28, 269–278 (2014). https://doi.org/10.1038/eye.2013.245
Received:
Accepted:
Published:
Issue date:
DOI: https://doi.org/10.1038/eye.2013.245
Keywords
This article is cited by
-
Predictive factors for treatment outcomes with intravitreal anti-vascular endothelial growth factor injections in diabetic macular edema in clinical practice
International Journal of Retina and Vitreous (2023)
-
Angiographic biomarkers are significant predictors of treatment response to intravitreal aflibercept in diabetic macular edema
Scientific Reports (2023)
-
Effect of age on response to anti-VEGF agents in patients with center involving diabetic macular edema in a tertiary hospital
International Journal of Retina and Vitreous (2022)
-
Factors associated with 1-year visual response following intravitreal bevacizumab treatment for diabetic macular edema: a retrospective single center study
International Journal of Retina and Vitreous (2021)
-
Differences in the characteristics of subjects achieving complete, partial, or no resolution of macular edema in the READ-3 study
Graefe's Archive for Clinical and Experimental Ophthalmology (2021)
