Effects of medical therapies on retinopathy progression in type 2 diabetes
Open accessAbstract
BACKGROUND: We investigated whether intensive glycemic control, combination therapy for dyslipidemia, and intensive blood-pressure control would limit the progression of diabetic retinopathy in persons with type 2 diabetes. Previous data suggest that these systemic factors may be important in the development and progression of diabetic retinopathy. METHODS: In a randomized trial, we enrolled 10,251 participants with type 2 diabetes who were at high risk for cardiovascular disease to receive either intensive or standard treatment for glycemia (target glycated hemoglobin level, <6.0% or 7.0 to 7.9%, respectively) and also for dyslipidemia (160 mg daily of fenofibrate plus simvastatin or placebo plus simvastatin) or for systolic blood-pressure control (target, <120 or <140 mm Hg). A subgroup of 2856 participants was evaluated for the effects of these interventions at 4 years on the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale (as assessed from seven-field stereoscopic fundus photographs, with 17 possible steps and a higher number of steps indicating greater severity) or the development of diabetic retinopathy necessitating laser photocoagulation or vitrectomy. RESULTS: At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; 95% confidence interval [CI], 0.51 to 0.87; P=0.003); 6.5% with fenofibrate for intensive dyslipidemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60; 95% CI, 0.42 to 0.87; P=0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio, 1.23; 95% CI, 0.84 to 1.79; P=0.29). CONCLUSIONS: Intensive glycemic control and intensive combination treatment of dyslipidemia, but not intensive blood-pressure control, reduced the rate of progression of diabetic retinopathy. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov numbers, NCT00000620 for the ACCORD study and NCT00542178 for the ACCORD Eye study.)
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In the ACCORD trial, intensive therapy targeting an A1C <6.0% did not significantly reduce the primary composite major CV outcomes compared with standard therapy targeting an A1C of 7.0% to 7.9% (HR 0.90, p=0.16).
“The primary composite major CV outcomes (nonfatal MI, nonfatal stroke or death from CV causes) were not reduced significantly in ACCORD (hazard ratio [HR] 0.90, p=0.16).”
From Targets for Glycemic Control (2018) · cites this paper as [21]
Methods > The ACCORD Study (page not provided) gives the A1C targets and defines the primary cardiovascular composite as nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. The cited paper does not report the claimed nonsignificant result, HR 0.90, or p=0.16 for that outcome; its reported treatment results concern retinopathy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIn people with type 2 diabetes, an A1C ≤6.5% may be targeted to reduce the risk of CKD and retinopathy, if they are assessed to be at low risk of hypoglycemia based on class of antihyperglycemic medication(s) utilized and the person's characteristics.
“In people with type 2 diabetes, an A1C ≤6.5% may be targeted to reduce the risk of CKD [Grade A, Level 1A (23)] and retinopathy [Grade A, Level 1A (21)], if they are assessed to be at low risk of hypoglycemia based on class of antihyperglycemic medication(s) utilized and the person's characteristics [Grade D, Consensus].”
From Targets for Glycemic Control (2018) · cites this paper as [21]
The Results report less retinopathy progression with intensive glycemic therapy (7.3% versus 10.4%); the intensive group's median A1C at one year was 6.4%. However, the Methods specify a target below 6.0%, not ≤6.5%, so this study supports intensive control for retinopathy but does not directly test the cited threshold. CKD and the hypoglycemia-risk qualification have separate attributions in the citing sentence. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe UK Prospective Diabetes Study randomly assigned 4209 patients with newly diagnosed type 2 diabetes to receive conventional vs intensive treatment, with mean attained HbA1C of 7.9% vs 7.0%, respectively.
“The UK Prospective Diabetes Study randomly assigned 4209 patients with newly diagnosed type 2 diabetes to receive conventional (primarily diet) vs intensive (insulin, sulfonylurea, or, if overweight, metformin) treatment, with mean attained HbA1C of 7.9% vs 7.0%, respectively.36,37”
From Diagnosis and Treatment of Type 2 Diabetes in Adults (2025) · cites this paper as [36]
The References section identifies UKPDS 33 as comparing intensive blood-glucose control with sulfonylureas or insulin against conventional treatment in patients with type 2 diabetes. Our copy does not give the claimed 4209 participants, newly diagnosed status, metformin or diet regimens, or attained HbA1c values of 7.9% and 7.0%. (LLM, conf=0.82)
Experimental — accuracy not yet measuredLifestyle intervention or bariatric surgery in T2D, or physical activity in T1D, can stabilize retinopathy.
“Other options that can stabilize retinopathy include lifestyle intervention or bariatric surgery in persons with T2D or physical activity in persons with T1D.524–527”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [527]
The Methods and Discussion (pages not provided) examine intensive glycemic treatment, fenofibrate plus statin therapy, and blood-pressure treatment in people with type 2 diabetes. Our copy does not address whether lifestyle intervention, bariatric surgery, or physical activity stabilizes retinopathy; searches for those interventions returned no supporting passage. (LLM, conf=0.76)
Experimental — accuracy not yet measuredFenofibrate reduces the progression of diabetic retinopathy.
“Fenofibrate reduces the progression of diabetic retinopathy.413,414”
From 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias (2016) · cites this paper as [414]
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Individualizing Glycemic Targets in Type 2 Diabetes Mellitus: Implications of Recent Clinical Trials
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11. Microvascular Complications and Foot Care: <i>Standards of Medical Care in Diabetes−2020</i>
American Diabetes Association (2020) · Diabetes Care · doi:10.2337/dc20-s011 · Cited by 460 · see citing works
Classification, Pathophysiology, Diagnosis and Management of Diabetes Mellitus
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on behalf of the FIELD Study investigators, Davis, T. M. E., Ting, R., Best, J. D., Donoghoe, M. W., Drury, P. L., Sullivan, D. R., Jenkins, A. J., O’Connell, R. L., Whiting, M. J., et al. (2011) · Diabetologia · doi:10.1007/s00125-010-1951-1 · Cited by 371 · see citing works
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Chew, E. Y., Davis, M. D., Danis, R. P., Lovato, J. F., Perdue, L., Greven, C. M., GENUTH, S. M., Goff, D. C., Leiter, L. A., Ismail‐Beigi, F., et al. (2014) · Ophthalmology · doi:10.1016/j.ophtha.2014.07.019 · Cited by 325 · see citing works
Japanese Clinical Practice Guideline for Diabetes 2016
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Biomarkers in Diabetic Retinopathy
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Worsening of diabetic retinopathy with rapid improvement in systemic glucose control: A review
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10. Microvascular Complications and Foot Care: Standards of Medical Care in Diabetes—2018
American Diabetes Association (2017) · Diabetes Care · doi:10.2337/dc18-s010 · Cited by 308 · see citing works
Diabetic Macular Edema: Current Understanding, Molecular Mechanisms and Therapeutic Implications
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Garber, A. J., Abrahamson, M. J., Barzilay, J. I., Blonde, L., Bloomgarden, Z. T., Bush, M. A., Dagogo-Jack, S., DeFronzo, R. A., Einhorn, D., Fonseca, V. A., et al. (2019) · Endocrine Practice · doi:10.4158/cs-2018-0535 · Cited by 297 · see citing works
Hemmingsen, B., Lund, S. S., Gluud, C. N., Vaag, A. A., Almdal, T., & Wetterslev, J. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008143.pub4 · Cited by 287 · see citing works
RetractedDiabetic retinopathy: pathogenesis, clinical grading, management and future developments
Heng, L. Z., Comyn, O., Pető, T., Tadros, C., Ng, E., Sivaprasad, S., & Hykin, P. G. (2012) · Diabetic Medicine · doi:10.1111/dme.12089 · Cited by 286 · see citing works
Evaluating All Potential Oral Complications of Diabetes Mellitus
Verhulst, M. J. L., Loos, B. G., Gerdes, V. E. A., & Teeuw, W. J. (2019) · Frontiers in Endocrinology · doi:10.3389/fendo.2019.00056 · Cited by 283 · see citing works
New Fibrate Use and Acute Renal Outcomes in Elderly Adults: A Population-Based Study
Zhao, Y. Y., Weir, M. A., Manno, M., Cordy, P., Gomes, T., Hackam, D. G., Juurlink, D. N., Mamdani, M., Moist, L., Parikh, C. R., et al. (2012) · Annals of Internal Medicine · doi:10.7326/0003-4819-156-8-201204170-00401 · Cited by 258 · see citing works
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Sacks, F. M., Hermans, M. P., Fioretto, P., Valensi, P. E., Davis, T. M. E., Horton, E. S., Wanner, C., Al-Rubeaan, K. A., Aronson, R., Barzon, I., et al. (2013) · Circulation · doi:10.1161/circulationaha.113.002529 · Cited by 254 · see citing works
Pharmacological treatment of hyperglycemia in type 2 diabetes
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The Evolving Treatment of Diabetic Retinopathy
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Novel approaches for treating diabetic retinopathy based on recent pathogenic evidence
Simó, R., & Hernández, C. (2015) · Progress in Retinal and Eye Research · doi:10.1016/j.preteyeres.2015.04.003 · Cited by 243 · see citing works
Glycemic Goals in Diabetes: Trade-off Between Glycemic Control and Iatrogenic Hypoglycemia
Cryer, P. E. (2014) · Diabetes · doi:10.2337/db14-0059 · Cited by 233 · see citing works
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Tay, J., Thompson, C. H., Luscombe‐Marsh, N. D., Wycherley, T. P., Noakes, M., Buckley, J. D., Wittert, G. A., Yancy, W. S., & Brinkworth, G. D. (2018) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13164 · Cited by 215 · see citing works
Diabetic retinopathy and diabetic macular oedema pathways and management: UK Consensus Working Group
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12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes—2024
ElSayed, N. A., Aleppo, G., Bannuru, R. R., Bruemmer, D., Collins, B. S., Ekhlaspour, L., Gibbons, C. H., Giurini, J. M., Hilliard, M. E., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc24-s012 · Cited by 245 · see citing works
Yue, T., Shi, Y., Luo, S., Weng, J., Wu, Y., & Zheng, X. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.1055087 · Cited by 224 · see citing works
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Mechanistic Insights into Pathological Changes in the Diabetic Retina
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Hemmingsen, B., Lund, S. S., Gluud, C. N., Vaag, A. A., Almdal, T., & Wetterslev, J. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008143.pub3 · Cited by 203 · see citing works
RetractedDiabetic retinopathy: a complex pathophysiology requiring novel therapeutic strategies
Whitehead, M. A., Wickremasinghe, S., Osborne, A., van Wijngaarden, P., & Martin, K. R. G. (2018) · Expert Opinion on Biological Therapy · doi:10.1080/14712598.2018.1545836 · Cited by 198 · see citing works
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Nine-year effects of 3.7 years of intensive glycemic control on cardiovascular outcomes
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Self-citationOxidative stress and reactive oxygen species: a review of their role in ocular disease
Ung, L., Pattamatta, U., Carnt, N. A., Wilkinson‐Berka, J. L., Liew, G., & White, A. J. R. (2017) · Clinical Science · doi:10.1042/cs20171246 · Cited by 193 · see citing works
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Self-citationTherapeutic Effects of PPARα Agonists on Diabetic Retinopathy in Type 1 Diabetes Models
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Inflammation in the pathogenesis of microvascular complications in diabetes
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Japanese Clinical Practice Guideline for Diabetes 2016
Haneda, M., Noda, M., Origasa, H., Noto, H., Yabe, D., Fujita, Y., Goto, A., Kondo, T., & Araki, E. (2018) · Journal of Diabetes Investigation · doi:10.1111/jdi.12810 · Cited by 183 · see citing works
10. Microvascular Complications and Foot Care
American Diabetes Association (2016) · Diabetes Care · doi:10.2337/dc17-s013 · Cited by 181 · see citing works
12. Retinopathy, Neuropathy, and Foot Care: <i>Standards of Medical Care in Diabetes—2022</i>
American Diabetes Association Professional Practice Committee (2022) · Diabetes Care · doi:10.2337/dc22-s012 · Cited by 177 · see citing works
Application of Random Forests Methods to Diabetic Retinopathy Classification Analyses
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12. Retinopathy, Neuropathy, and Foot Care: <i>Standards of Care in Diabetes—2023</i>
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12. Retinopathy, Neuropathy, and Foot Care: Standards of Care in Diabetes—2025
American Diabetes Association Professional Practice Committee, ElSayed, N. A., McCoy, R. G., Aleppo, G., Balapattabi, K., Beverly, E. A., Briggs Early, K., Bruemmer, D., Callaghan, B. C., Echouffo-Tcheugui, J. B., et al. (2025) · Diabetes Care · doi:10.2337/dc25-s012 · Cited by 176 · see citing works
- Authors
- The ACCORD Study Group and ACCORD Eye Study Group
- Corresponding author
- The ACCORD Study Group and ACCORD Eye Study Group
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-07-15
- Volume
- 363
- Issue
- 3
- Pages
- 233-244
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4026164
- OpenAlex
- W2219384223
- Semantic Scholar
- 9a607a3bfd9432a917f703d573fdaa1052647711
- Cited by
- 1,311
- References
- 36
- Citations by year
- 2026: 54 · 2025: 60 · 2024: 66 · 2023: 86 · 2022: 73 · 2021: 94 · 2020: 96 · 2019: 57 · 2018: 78 · 2017: 87 · 2016: 82 · 2015: 84 · 2014: 74 · 2013: 81 · 2012: 93
- FWCI
- 111.95
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Abbott Laboratories
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Regeneron Pharmaceuticals
- Massachusetts Medical Society
- Omron Healthcare
- Bayer HealthCare
- Daiichi-Sankyo
- Novo Nordisk
- Servier
- National Institutes of Health (n01hc95183-23-0-0, n01hc95180-24-0-1, n01hc95184-24-0-1, n01hc95181-23-0-1, n01hc95182-23-0-1, Z99 EY999999, n01hc95178-28-0-1, n01hc95179-25-0-0)
- Centers for Disease Control and Prevention
- National Institute on Aging
- National Heart, Lung, and Blood Institute (N01- HC-95181, R01HL073030, N01 HC095184, N01-HC- 95180, N01-HC-95178, N01 HC095182, N01 HC095181, Y01 HC001010, N01-HC-095183, N01 HC095178, N01-HC-95184, N01HC95179, IAAY1-HC-1010, IAA #Y1-HC-9035, N01 HC095180, Y01 HC009035, N01‐HC‐95183, N01-HC-95182, N01 HC095179)
- National Eye Institute (ZIAEY000410)
- National Institute of Diabetes and Digestive and Kidney Diseases
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- diabetic retinopathy, retinopathy progression, type 2 diabetes, tight glycemic control, HbA1c, fenofibrate, simvastatin, dyslipidemia, blood pressure control, laser photocoagulation, vitrectomy, cardiovascular risk reduction, combination therapy, Early Treatment Diabetic Retinopathy Study
- MeSH terms
- Antihypertensive Agents, Hypolipidemic Agents, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Retinopathy, Drug Therapy, Combination, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Hyperglycemia, Hypertension, Hypoglycemic Agents, Cholesterol, LDL, Male, Middle Aged, Fenofibrate, Disease Progression, Simvastatin, Dyslipidemias
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