Diabetic RetinopathyPhase 3NCT00542178

Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)

A Phase 3 study testing Hypoglycemic Agents, Intensive BP treatment and Fenofibrate in people with Diabetic Retinopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. Read more about this study

Who is it for?: Ages 40 to 79 years
Conditions the study is for: Diabetic Retinopathy
What is being tested?: Hypoglycemic Agents, Intensive BP treatment and Fenofibrate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,472 participants
Where: 7 sitesin 2 countries
Study dates: Oct 2003to Dec 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participating in the ACCORD study

Who cannot join

Has had laser photocoagulation for DR
Has had vitrectomy surgery for DR

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

United States6 sites

Case Western Reserve University
Cleveland, Ohio, 44106-4951
Veterans Affairs
Memphis, Tennessee, 38104-2193
The Berman Center for Clinical Research
Minneapolis, Minnesota, 55404
Columbia University
New York, New York, 10032
University of Washington
Seattle, Washington, 98109
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

Canada1 site

McMaster University
Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

Official title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study

Read the detailed description

DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabetes. Older people have an increased risk of developing DR; however, DR is likely to occur earlier and be more severe in anyone who has poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the effects of different treatments on cardiovascular disease in people with diabetes. Participants in the ACCORD study will receive one of eight different combinations of treatment, including blood sugar control, blood pressure control, and cholesterol-controlling medication. This study will enroll participants in the ACCORD study and will examine the effects of the study treatments on DR. The results from this study may be used to develop new treatments to help prevent diabetes-related blindness.

Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.

Conditions: Diabetic Retinopathy
Being tested: Hypoglycemic Agents, Standard glycemia control, Intensive BP treatment, Standard BP control, Fenofibrate
Keywords: Type 2 Diabetes Mellitus, Cardiovascular Diseases
Medical subject headings: Diabetic Retinopathy, Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypoglycemic AgentsDrug
Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%
Standard glycemia controlDrug
A strategy of glycemia drugs for HbA1c 7% - 7.9%
Intensive BP treatmentDrug
A strategy of multiple BP agents to reduce SBP less than 120 mm Hg
Standard BP controlDrug
A strategy of BP drugs for SBP less than 140 mm Hg
FenofibrateDrug
Blinded fenofibrate
SimvastatinDrug
Simvastatin 20-40 mg/d
PlaceboDrug
Placebo

Study groups in NCT00542178
Study group	Role	What they receive
Intensive glycemia control	Experimental	A strategy of intensive glycemia treatment to HbA1c less than 6% Receives: Drug: Hypoglycemic Agents
Standard glycemia control	Active comparator	A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% Receives: Drug: Standard glycemia control
Intensive BP control	Experimental	A strategy of BP treatment for SBP less than 120 mm Hg Receives: Drug: Intensive BP treatment
Standard BP control	Active comparator	A strategy of BP treatment for SBP less than 140 mm Hg Receives: Drug: Standard BP control
Fibrate	Experimental	Blinded fenofibrate + simvastatin 20-40 mg/d Receives: Drug: Fenofibrate; Drug: Simvastatin
Fibrate Placebo	Placebo comparator	Blinded placebo + simvastatin 20-40 mg/d Receives: Drug: Simvastatin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy
Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.
Measured: Measured at Year 4

Secondary outcomes (3)

Loss of Visual Acuity
Measured: Measured at Year 4
Cataract Extraction
Measured: Measured at Year 4
Development or Progression of Macular Edema
Measured: Measured at Year 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2003Dec 2009

First posted10 Oct 2007 (estimated)
Study startOct 2003
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,472 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00542178
Sponsor's protocol ID: 509
Other IDs: N01 HC095178-19, N01HC095178
Status last verified: Oct 2016
First submitted: 9 Oct 2007
Last updated: 24 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. doi: 10.1016/j.amjcard.2007.03.028. Epub 2007 Apr 13.
PubMed 17599420
ACCORD Study Group; ACCORD Eye Study Group; Chew EY, Ambrosius WT, Davis MD, Danis RP, Gangaputra S, Greven CM, Hubbard L, Esser BA, Lovato JF, Perdue LH, Goff DC Jr, Cushman WC, Ginsberg HN, Elam MB, Genuth S, Gerstein HC, Schubart U, Fine LJ. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010 Jul 15;363(3):233-44. doi: 10.1056/NEJMoa1001288. Epub 2010 Jun 29.
PubMed 20587587
Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.
PubMed 36975019
Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Eye Study Group and the Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Study Group. Persistent Effects of Intensive Glycemic Control on Retinopathy in Type 2 Diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study. Diabetes Care. 2016 Jul;39(7):1089-100. doi: 10.2337/dc16-0024. Epub 2016 Jun 11.
PubMed 27289122
Chew EY, Davis MD, Danis RP, Lovato JF, Perdue LH, Greven C, Genuth S, Goff DC, Leiter LA, Ismail-Beigi F, Ambrosius WT; Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology. 2014 Dec;121(12):2443-51. doi: 10.1016/j.ophtha.2014.07.019. Epub 2014 Aug 29.
PubMed 25172198
Wong TY, Simo R, Mitchell P. Fenofibrate - a potential systemic treatment for diabetic retinopathy? Am J Ophthalmol. 2012 Jul;154(1):6-12. doi: 10.1016/j.ajo.2012.03.013.
PubMed 22709833
Ambrosius WT, Danis RP, Goff DC Jr, Greven CM, Gerstein HC, Cohen RM, Riddle MC, Miller ME, Buse JB, Bonds DE, Peterson KA, Rosenberg YD, Perdue LH, Esser BA, Seaquist LA, Felicetta JV, Chew EY; ACCORD Study Group. Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy. Arch Ophthalmol. 2010 Mar;128(3):312-8. doi: 10.1001/archophthalmol.2009.310.
PubMed 20212201

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study
ClinicalTrials.gov ID: NCT00542178
Acronym / sponsor ID: 509
Conditions: Diabetic Retinopathy
Keywords: Type 2 Diabetes Mellitus, Cardiovascular Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,472 participants (actual)
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
Collaborators: National Eye Institute (NEI)
Study start: Oct 2003
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 10 Oct 2007 (estimated)
Results: Posted 26 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Intensive glycemia control	Experimental	Drug: Hypoglycemic AgentsA strategy of intensive glycemia treatment to HbA1c less than 6%
Standard glycemia control	Active comparator	Drug: Standard glycemia controlA strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
Intensive BP control	Experimental	Drug: Intensive BP treatmentA strategy of BP treatment for SBP less than 120 mm Hg
Standard BP control	Active comparator	Drug: Standard BP controlA strategy of BP treatment for SBP less than 140 mm Hg
Fibrate	Experimental	Drug: Fenofibrate, Drug: SimvastatinBlinded fenofibrate + simvastatin 20-40 mg/d
Fibrate Placebo	Placebo comparator	Drug: Simvastatin, Drug: PlaceboBlinded placebo + simvastatin 20-40 mg/d

Who may qualify

Ages: 40 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participating in the ACCORD study

Key exclusion criteria (2 listed)

Has had laser photocoagulation for DR
Has had vitrectomy surgery for DR

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypoglycemic AgentsMultiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%	Drug	Intensive glycemia control
Standard glycemia controlA strategy of glycemia drugs for HbA1c 7% - 7.9%	Drug	Standard glycemia control
Intensive BP treatmentA strategy of multiple BP agents to reduce SBP less than 120 mm Hg	Drug	Intensive BP control
Standard BP controlA strategy of BP drugs for SBP less than 140 mm Hg	Drug	Standard BP control
FenofibrateBlinded fenofibrate	Drug	Fibrate
SimvastatinSimvastatin 20-40 mg/d	Drug	Fibrate, Fibrate Placebo
PlaceboPlacebo	Drug	Fibrate Placebo

Primary outcome

Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy
Time frame: Measured at Year 4
Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher.

3 secondary outcomes

Loss of Visual Acuity
Time frame: Measured at Year 4
Cataract Extraction
Time frame: Measured at Year 4
Development or Progression of Macular Edema
Time frame: Measured at Year 4

Results and safety

Results posted to the registry on 26 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intensive Glycemia Control & Intensive Blood Pressure Control	390	315
Standard Glycemia Control & Intensive Blood Pressure Control	412	332
Intensive Glycemia Control & Standard Blood Pressure Control	382	308
Standard Glycemia Control & Standard Blood Pressure Control	370	308
Intensive Glycemia Control & Fibrate	464	400
Standard Glycemia Control & Fibrate	495	406
Intensive Glycemia Control & Fibrate Placebo	493	406
Standard Glycemia Control & Fibrate Placebo	466	381

Primary outcome: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy

Time frame: Measured at Year 4. Number. Unit: participants

Measure	Intensive Glycemia Control n = 1429	Standard Glycemia Control n = 1427	Intensive Blood Pressure Control n = 647	Standard Blood Pressure Control n = 616	Fenofibrate + Simvastatin Therapy n = 806	Placebo + Simvastatin Therapy n = 787
Value	104	149	67	54	52	80

Intensive Glycemia Control vs Standard Glycemia Control: Odds Ratio (OR): 0.67 (95% CI 0.51 to 0.87), p = 0.003, Regression, Logistic
Intensive Blood Pressure Control vs Standard Blood Pressure Control: Odds Ratio (OR): 1.23 (95% CI 0.84 to 1.79), p = 0.29, Regression, Logistic
Fenofibrate + Simvastatin Therapy vs Placebo + Simvastatin Therapy: Odds Ratio (OR): 0.60 (95% CI 0.42 to 0.87), p = 0.006, Regression, Logistic

Population analysed: The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Entire duration of the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intensive Glycemia Control	0 of 0	0 of 0	Not reported
Standard Glycemia Control	0 of 0	0 of 0	Not reported
Intensive BP Control	0 of 0	0 of 0	Not reported
Standard BP Control	0 of 0	0 of 0	Not reported
Fibrate	0 of 0	0 of 0	Not reported
Fibrate Placebo	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): The glycemia trial was stopped early, potentially underestimating the reported effect of glycemia treatment on diabetic retinopathy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17599420Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M; ACCORD Study Group. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol. 2007 Jun 18;99(12A):103i-111i. doi: 10.1016/j.amjcard.2007.03.028. Epub 2007 Apr 13.
Results publication: PubMed 20587587ACCORD Study Group; ACCORD Eye Study Group; Chew EY, Ambrosius WT, Davis MD, Danis RP, Gangaputra S, Greven CM, Hubbard L, Esser BA, Lovato JF, Perdue LH, Goff DC Jr, Cushman WC, Ginsberg HN, Elam MB, Genuth S, Gerstein HC, Schubart U, Fine LJ. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med. 2010 Jul 15;363(3):233-44. doi: 10.1056/NEJMoa1001288. Epub 2010 Jun 29.
Derived from this study: PubMed 36975019Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.
Derived from this study: PubMed 27289122Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Eye Study Group and the Action to Control Cardiovascular Risk in Diabetes Follow-On (ACCORDION) Study Group. Persistent Effects of Intensive Glycemic Control on Retinopathy in Type 2 Diabetes in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Follow-On Study. Diabetes Care. 2016 Jul;39(7):1089-100. doi: 10.2337/dc16-0024. Epub 2016 Jun 11.
Derived from this study: PubMed 25172198Chew EY, Davis MD, Danis RP, Lovato JF, Perdue LH, Greven C, Genuth S, Goff DC, Leiter LA, Ismail-Beigi F, Ambrosius WT; Action to Control Cardiovascular Risk in Diabetes Eye Study Research Group. The effects of medical management on the progression of diabetic retinopathy in persons with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology. 2014 Dec;121(12):2443-51. doi: 10.1016/j.ophtha.2014.07.019. Epub 2014 Aug 29.
Derived from this study: PubMed 22709833Wong TY, Simo R, Mitchell P. Fenofibrate - a potential systemic treatment for diabetic retinopathy? Am J Ophthalmol. 2012 Jul;154(1):6-12. doi: 10.1016/j.ajo.2012.03.013.
Derived from this study: PubMed 20212201Ambrosius WT, Danis RP, Goff DC Jr, Greven CM, Gerstein HC, Cohen RM, Riddle MC, Miller ME, Buse JB, Bonds DE, Peterson KA, Rosenberg YD, Perdue LH, Esser BA, Seaquist LA, Felicetta JV, Chew EY; ACCORD Study Group. Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy. Arch Ophthalmol. 2010 Mar;128(3):312-8. doi: 10.1001/archophthalmol.2009.310.
Click here for the ACCORD Study Web siteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Walter T. Ambrosius, PhD principal investigator

Wake Forest University Health Sciences

Emily Y. Chew, MD principal investigator

National Eye Institute (NEI)

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (time frame: Measured at Year 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00542178, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.