The Course of Response to Focal Photocoagulation for DME
Laser Resp
4 other identifiers
observational
122
1 country
32
Brief Summary
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.
- Treatment is to be deferred and follow up continued if visual acuity letter score has improved by \>5 or OCT central subfield thickness has decreased by \>10% compared with baseline.
- If visual acuity letter score has not improved by at least 5 and OCT central subfield thickness has not decreased by at least 10%, then the eye is classified as 'not improved' and the investigator may provide additional treatment. Follow up ends for eyes that receive additional treatment at this visit. However, if the investigator and participant elect to defer additional treatment (even if deferral criteria are not met), then follow up will continue until the study eye receives additional treatment for DME.
- Eyes continuing in follow up have visits every 8 weeks (+1week) as long as there has been continued improvement in visual acuity (letter score improved \>5 ) or retinal thickness (central subfield thickness decreased by \>10%) compared with the visit 16 weeks earlier. The longest follow-up time will be 48 weeks. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2007
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedAugust 26, 2016
August 1, 2016
1.4 years
February 27, 2007
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OCT-measured retinal thickness and visual acuity
16 weeks
Study Arms (1)
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
Interventions
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
Eligibility Criteria
Diabetics within the United States who are at least 18 years old and have DME treatable with laser photocoagulation.
You may qualify if:
- Age \>= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2.
- At least one eye meets the study eye criteria.
- Able and willing to provide informed consent.
You may not qualify if:
- Best corrected E-ETDRS visual acuity letter score \>= 24 (i.e., 20/320 or better) within 8 days of enrollment.
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
- OCT central subfield \>=250 microns within 8 days of enrollment.
- Media clarity, pupillary dilation, and subject cooperation sufficient for adequate OCT.
- Investigator believes that focal photocoagulation is the most appropriate treatment for the DME.
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110).
- Participation in an investigational trial within 30 days of enrollment that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next 6 months.
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, significant macular ischemia, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
- History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
Study Sites (32)
Southern California Desert Retina Consultants, MC
Palm Springs, California, 92262, United States
Retina Vitreous Consultants
Fort Lauderdale, Florida, 33484, United States
Retina Consultants of Southwest Florida
Fort Myers, Florida, 33912, United States
Central Florida Retina Institute
Lakeland, Florida, 33805, United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
Retina Associates of Hawaii, Inc.
Honolulu, Hawaii, 96813, United States
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, 46290, United States
American Eye Institute
New Albany, Indiana, 47150, United States
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky, 40509, United States
Paducah Retinal Center
Paducah, Kentucky, 42001, United States
Maine Vitreoretinal Consultants
Bangor, Maine, 04401, United States
Elman Retina Group, P.A.
Baltimore, Maryland, 21237, United States
Southern New England Retina Associates
Attleboro, Massachusetts, 02703, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525, United States
Associated Retina Consultants
Williamsburg, Michigan, 49690, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
University of Rochester
Rochester, New York, 14642, United States
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York, 13224, United States
University of North Carolina, Dept. of Ophthalmology
Chapel Hill, North Carolina, 27599, United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina, 28210, United States
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, 44122, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Palmetto Retina Center
Columbia, South Carolina, 29169, United States
Carolina Retina Center
Columbia, South Carolina, 29223, United States
Retina Research Center
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Charles A. Garcia, PA & Associates
Houston, Texas, 77002, United States
Retina and Vitreous of Texas
Houston, Texas, 77025, United States
Texas Retina Associates
Lubbock, Texas, 79424, United States
University of Wisconsin-Madison, Dept. of Ophthalmology
Madison, Wisconsin, 53705, United States
Related Publications (1)
Diabetic Retinopathy Clinical Research Network. The course of response to focal/grid photocoagulation for diabetic macular edema. Retina. 2009 Nov-Dec;29(10):1436-43. doi: 10.1097/IAE.0b013e3181bcef6b.
PMID: 19898182RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Browning, M.D.
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2007
First Posted
March 1, 2007
Study Start
January 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
August 26, 2016
Record last verified: 2016-08