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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: | NCT00442156 |
Purpose
The study objective is to determine the course of changes in OCT measured macular thickness and visual acuity following a single session of focal photocoagulation for center-involved DME. The response will be evaluated separately in eyes with and without prior focal photocoagulation for DME. The purpose is to determine the proportion of eyes that continue to improve at least 5 letters in visual acuity or at least 10% in central retinal thickness after a session of focal photocoagulation. In addition, the study will explore whether any baseline factors can be identified that are predictive of the response.
All subjects will have follow-up visits 8 weeks and 16 weeks post treatment. At the 16-week visit, study eyes are evaluated for change in retinal thickness and visual acuity from baseline.
By providing information on the length of time during which clinically meaningful improvement occurs following focal photocoagulation, clinicians will be better able to determine when further photocoagulation or other treatments should be considered for persistent DME. Depending on the results of this study, a future randomized clinical trial will be considered comparing the more aggressive retreatment photocoagulation regimen currently serving as the standard DRCR Network approach to focal photocoagulation for macular edema with the less aggressive regimen evaluated in this protocol.
| Condition | Intervention |
|---|---|
|
Diabetic Retinopathy Diabetic Macular Edema |
Procedure: Laser photocoagulation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Course of Response to Focal Photocoagulation for Diabetic Macular Edema |
| Enrollment: | 122 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Laser
People with diabetic macular edema involving the center of the macula (OCT central subfield thickness >250 microns), who were already intended to receive focal photocoagulation
|
Procedure: Laser photocoagulation
modified ETDRS focal photocoagulation generally completed in a single sitting on the day of enrollment, but if little or no improvement, may be repeated at 16 weeks
Other Name: Laser
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Diabetics within the United States who are at least 18 years old and have DME treatable with laser photocoagulation.
Inclusion Criteria
To be eligible, the following inclusion criteria must be met:
The subject must have one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. If both eyes are eligible, the study eye is selected by the investigator and subject.
Exclusion Criteria
A subject is not eligible if any of the following exclusion criteria are present:
The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
Contacts and Locations
Show 32 Study Locations| Study Chair: | David Browning, M.D. | Charlotte Eye, Ear, Nose and Throat Assoc., PA |
More Information
| Responsible Party: | Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research (DRCR.net) |
| ClinicalTrials.gov Identifier: | NCT00442156 History of Changes |
| Other Study ID Numbers: | NEI-131, U10EY018817-03, U10EY014229-07, U10EY014231-09 |
| Study First Received: | February 27, 2007 |
| Last Updated: | March 18, 2011 |
| Health Authority: | United States: Federal Government |
|
Laser photocoagulation |
|
Diabetic Retinopathy Edema Macular Edema Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Signs and Symptoms Macular Degeneration Retinal Degeneration |