Trial · NCT00542178
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
NCT00542178, Phase 3, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2013-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study). Trials, record NCT00542178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00542178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
- NCT number
- NCT00542178
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,472 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Diabetic Retinopathy
- Interventions
- Hypoglycemic Agents, Standard glycemia control, Intensive BP treatment, Standard BP control, Fenofibrate, Simvastatin, Placebo
- First posted
- 2007-10-10
- Last updated
- 2018-07-24
- Results first posted
- 2013-11-26
- Limitations and caveats
- The glycemia trial was stopped early, potentially underestimating the reported effect of glycemia treatment on diabetic retinopathy.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | Loss of Visual Acuity | Measured at Year 4 | |
| Secondary | Cataract Extraction | Measured at Year 4 | |
| Secondary | Development or Progression of Macular Edema | Measured at Year 4 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Measured at Year 4 | The ACCORD Eye study recruited 3472 eligible participants. Of these, 2856 participants had both baseline and year 4 follow-up data available for analyses. | participants | NUMBER |
| SECONDARY | Loss of Visual Acuity | Measured at Year 4 | Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information about loss in visual acuity. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cataract Extraction | Measured at Year 4 | Subset of Participants from the entire ACCORD cohort (NCT00000620) who provided information regarding whether or not they had a cataract extraction. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Development or Progression of Macular Edema | Measured at Year 4 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Intensive Glycemia Control | 104 | participants | ||
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 | Standard Glycemia Control | 149 | participants | ||
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 | Intensive Blood Pressure Control | 67 | participants | ||
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 | Standard Blood Pressure Control | 54 | participants | ||
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 | Fenofibrate + Simvastatin Therapy | 52 | participants | ||
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 | Placebo + Simvastatin Therapy | 80 | participants | ||
| Loss of Visual Acuity | Intensive Glycemia Control | 744 | Participants | ||
| Loss of Visual Acuity | Standard Glycemia Control | 752 | Participants | ||
| Loss of Visual Acuity | Intensive Blood Pressure Control | 367 | Participants | ||
| Loss of Visual Acuity | Standard Blood Pressure Control | 382 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intensive Glycemia Control & Intensive Blood Pressure Control | 390 | |
| Overall Study | STARTED | Standard Glycemia Control & Intensive Blood Pressure Control | 412 | |
| Overall Study | STARTED | Intensive Glycemia Control & Standard Blood Pressure Control | 382 | |
| Overall Study | STARTED | Standard Glycemia Control & Standard Blood Pressure Control | 370 | |
| Overall Study | STARTED | Intensive Glycemia Control & Fibrate | 464 | |
| Overall Study | STARTED | Standard Glycemia Control & Fibrate | 495 | |
| Overall Study | STARTED | Intensive Glycemia Control & Fibrate Placebo | 493 | |
| Overall Study | STARTED | Standard Glycemia Control & Fibrate Placebo | 466 | |
| Overall Study | COMPLETED | Intensive Glycemia Control & Intensive Blood Pressure Control | 315 | |
| Overall Study | COMPLETED | Standard Glycemia Control & Intensive Blood Pressure Control | 332 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intensive Glycemia Control | ||
| Total, all-cause mortality | Standard Glycemia Control | ||
| Total, all-cause mortality | Intensive BP Control | ||
| Total, all-cause mortality | Standard BP Control | ||
| Total, all-cause mortality | Fibrate | ||
| Total, all-cause mortality | Fibrate Placebo | ||
| Total, other adverse events | Intensive Glycemia Control | 0 | 0 |
| Total, other adverse events | Standard Glycemia Control | 0 | 0 |
| Total, other adverse events | Intensive BP Control | 0 | 0 |
| Total, other adverse events | Standard BP Control | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| N01HC095178 | PREVENTION OF CARDIOVASCULAR DISEASE IN DIABETES MELLITU-268995178-268095178 | BYINGTON, ROBERT | WAKE FOREST UNIVERSITY HEALTH SCIENCES | DIVISION OF EPIDEMIOLOGY AND CLINICAL APPLICATIONS | 1999 to 2006 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00542178
GET https://conductscience.org/api/trials/v1/NCT00542178/results?page=2