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| Sponsor: | Diabetic Retinopathy Clinical Research Network |
|---|---|
| Collaborator: |
National Eye Institute (NEI) |
| Information provided by: | Diabetic Retinopathy Clinical Research Network |
| ClinicalTrials.gov Identifier: | NCT00071773 |
Purpose
This pilot study will compare the use of current laser treatment for diabetic macular edema with a similar laser treatment that is milder in intensity, but more extensive.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Macular Edema |
Procedure: modified-ETDRS photocoagulation Procedure: Mild Macular Grid photocoagulation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema |
| Enrollment: | 263 |
| Study Start Date: | July 2003 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Modified Early Treatment Diabetic Retinopathy Study (ETDRS)
modified-ETDRS
|
Procedure: modified-ETDRS photocoagulation
A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
Other Name: focal/grid photocoagulation
|
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Active Comparator: Mild Macular Grid (MMG)
MMG technique
|
Procedure: Mild Macular Grid photocoagulation
A treatment session can be given in single or multiple sittings at the investigator's discretion, as long as the entire treatment session is completed within 6 weeks. Retreatment in Phase 1 of the study should only occur at the 3.5 and 8 month visits.
Other Name: mmg photocoagulation
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Current regular use of insulin for the treatment of diabetes; Current regular use of oral antihyperglycemia agents for the treatment of diabetes; Documented diabetes by ADA guidelines (see DRCR.net Procedures Manual).
Study Eye Criteria:
At least one eye must meet all of the following criteria:
A patient may have two "study eyes" only if both are eligible at the time of randomization. An eye that becomes eligible after randomization will not be considered a study eye for purposes of data analyses or treatment decisions although information is being gathered on all eyes)
Contacts and Locations
More Information
| Responsible Party: | Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net) |
| ClinicalTrials.gov Identifier: | NCT00071773 History of Changes |
| Other Study ID Numbers: | NEI-113, U10EY018817-03, U10EY014229-07, U10EY014231-09 |
| Study First Received: | October 30, 2003 |
| Last Updated: | March 18, 2011 |
| Health Authority: | United States: Federal Government |
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diabetic macular edema laser photocoagulation etdrs macular grid photocoagulation DME |
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Edema Macular Edema Signs and Symptoms Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |