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The Course of Response to Focal Photocoagulation for DME (Laser Resp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442156
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : August 26, 2016
National Eye Institute (NEI)
Information provided by:
Jaeb Center for Health Research

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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Diabetic Macular Edema Procedure: Laser photocoagulation

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Course of Response to Focal Photocoagulation for Diabetic Macular Edema
Study Start Date : January 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. OCT-measured retinal thickness and visual acuity [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

  • 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.

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.

  • 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.
  • Study Eye Exclusion Criteria

Exclusion Criteria

A subject is not eligible if any of the following exclusion criteria are present:

  • 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.

The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):

  • 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).
  • History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to enrollment or anticipated to be performed within next 6 months.
  • History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months.
  • History of YAG capsulotomy performed within 2 months prior to enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442156

Hide Hide 32 study locations
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United States, California
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262
United States, Florida
Retina Consultants of Southwest Florida
Fort Myers, Florida, United States, 33912
Retina Vitreous Consultants
Ft. Lauderdale, Florida, United States, 33484
Central Florida Retina Institute
Lakeland, Florida, United States, 33805
United States, Georgia
Southeast Retina Center, P.C.
Augusta, Georgia, United States, 30909
United States, Hawaii
Retina Associates of Hawaii, Inc.
Honolulu, Hawaii, United States, 96813
United States, Indiana
Raj K. Maturi, M.D., P.C.
Indianapolis, Indiana, United States, 46290
American Eye Institute
New Albany, Indiana, United States, 47150
United States, Kentucky
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky, United States, 40509
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
United States, Maine
Maine Vitreoretinal Consultants
Bangor, Maine, United States, 04401
United States, Maryland
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Southern New England Retina Associates
Attleboro, Massachusetts, United States, 02703
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States, 49525
Associated Retina Consultants
Williamsburg, Michigan, United States, 49690
United States, New Jersey
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States, 08648
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York, United States, 13224
United States, North Carolina
University of North Carolina, Dept. of Ophthalmology
Chapel Hill, North Carolina, United States, 27599
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina, United States, 28210
United States, Ohio
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, United States, 44122
United States, Oregon
Casey Eye Institute
Portland, Oregon, United States, 97239
United States, South Carolina
Palmetto Retina Center
Columbia, South Carolina, United States, 29169
Carolina Retina Center
Columbia, South Carolina, United States, 29223
United States, Texas
Retina Research Center
Austin, Texas, United States, 78705
Texas Retina Associates
Dallas, Texas, United States, 75231
Charles A. Garcia, PA & Associates
Houston, Texas, United States, 77002
Retina and Vitreous of Texas
Houston, Texas, United States, 77025
Texas Retina Associates
Lubbock, Texas, United States, 79424
United States, Wisconsin
University of Wisconsin-Madison, Dept. of Ophthalmology
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Jaeb Center for Health Research
National Eye Institute (NEI)
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Study Chair: David Browning, M.D. Charlotte Eye, Ear, Nose and Throat Assoc., PA
Publications of Results:
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Responsible Party: Roy W. Beck, M.D., Ph.D., Director, Jaeb Center for Health Research ( Identifier: NCT00442156    
Other Study ID Numbers: NEI-131
U10EY018817-03 ( U.S. NIH Grant/Contract )
U10EY014229-07 ( U.S. NIH Grant/Contract )
U10EY014231-09 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Keywords provided by Jaeb Center for Health Research:
Laser photocoagulation
Additional relevant MeSH terms:
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Retinal Degeneration
Retinal Diseases
Macular Edema
Diabetic Retinopathy
Macular Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases