Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000151
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
1999-09-23
Brief Title:
Early Treatment Diabetic Retinopathy Study ETDRS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
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 3711 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 20200 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 aspirins 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 aspirins 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 20200 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 aspirins 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 aspirins 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None