Phase 3
N=3,472
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT00542178 ↗Enrolled (actual)
3,472
Serious AEs
—
Results posted
Nov 2013
Primary outcome: 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 — 104; 149; 67; 54 participants — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hypoglycemic Agents (Drug); Standard glycemia control (Drug); Intensive BP treatment (Drug); Standard BP control (Drug); Fenofibrate (Drug); Simvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
104; 149; 67; 54; 52; 80 | 0.003 sig |
| SECONDARY Loss of Visual Acuity |
744; 752; 367; 382; 354; 393 | 0.96 |
| SECONDARY Cataract Extraction |
547; 623; 266; 300; 305; 299 | 0.0355 sig |
| SECONDARY Development or Progression of Macular Edema |
44; 40; 18; 20; 24; 22 | 0.069 |
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. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.
Eligibility Criteria
Inclusion Criteria
- Participating in the ACCORD study
Exclusion Criteria
- Has had laser photocoagulation for DR
- Has had vitrectomy surgery for DR
Data sourced from ClinicalTrials.gov (NCT00542178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.