Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT00000151
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
1999-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Treatment Diabetic Retinopathy Study (ETDRS)
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness.
To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy.
To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function.
To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.
To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy.
To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function.
To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.
Detailed Description:
ETDRS was a multicenter, randomized clinical trial designed to evaluate argon laser photocoagulation and aspirin treatment in the management of patients with nonproliferative or early proliferative diabetic retinopathy. A total of 3,711 patients were recruited to be followed for a minimum of 4 years to provide long-term information on the risks and benefits of the treatments under study.
The eligibility criteria for the ETDRS were designed to include a broad range of macular edema severity, from a few small hard exudates within a disc diameter of the fovea with normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. All study patients had one eye randomly assigned to immediate photocoagulation and the other eye to deferral of photocoagulation until high-risk proliferative retinopathy developed. During followup, additional photocoagulation was allowed for any degree of macular edema within the eligibility range, but additional photocoagulation was required only for edema involving or threatening the center of the macula. The term "clinically significant macular edema" was coined to designate this level of severity.
The trial use of aspirin therapy was based on clinical observation and on aspirin's possible mechanisms of action. Previous observations of diabetic patients who were taking large doses of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group was lower than the prevalence that would be expected in the diabetic population at large. Evidence suggested that diabetic patients have altered platelet aggregation and disaggregation, which may contribute to the capillary closure seen in retinopathy. This abnormality is reversed by aspirin in vitro . However, because of aspirin's other possible mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and intolerance reactions, the use of this therapy in the ETDRS was carefully controlled and monitored.
The eligibility criteria for the ETDRS were designed to include a broad range of macular edema severity, from a few small hard exudates within a disc diameter of the fovea with normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. All study patients had one eye randomly assigned to immediate photocoagulation and the other eye to deferral of photocoagulation until high-risk proliferative retinopathy developed. During followup, additional photocoagulation was allowed for any degree of macular edema within the eligibility range, but additional photocoagulation was required only for edema involving or threatening the center of the macula. The term "clinically significant macular edema" was coined to designate this level of severity.
The trial use of aspirin therapy was based on clinical observation and on aspirin's possible mechanisms of action. Previous observations of diabetic patients who were taking large doses of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group was lower than the prevalence that would be expected in the diabetic population at large. Evidence suggested that diabetic patients have altered platelet aggregation and disaggregation, which may contribute to the capillary closure seen in retinopathy. This abnormality is reversed by aspirin in vitro . However, because of aspirin's other possible mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and intolerance reactions, the use of this therapy in the ETDRS was carefully controlled and monitored.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: