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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Eye Institute (NEI) |
| 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: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| 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 |
|---|---|
|
1: Active Comparator
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.
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2: Active Comparator
MMG technique
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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.
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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: | Jaeb Center for Health Research (DRCR.net) ( Roy W. Beck, M.D., Ph.D., Director ) |
| Study ID Numbers: | NEI-113 |
| Study First Received: | October 30, 2003 |
| Last Updated: | September 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00071773 History of Changes |
| Health Authority: | United States: Federal Government |
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diabetic macular edema laser photocoagulation etdrs macular grid photocoagulation DME |
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Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases |