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Trial record 1 of 1 for:    Evaluation of Vitrectomy for Diabetic Macular Edema Study
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Evaluation of Vitrectomy for Diabetic Macular Edema (Vitrectomy-D)

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.
 
ClinicalTrials.gov Identifier: NCT00709319
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : April 2, 2012
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief Summary:

The study is designed as a prospective cohort study to assess changes in visual acuity and retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic macular edema.

The study also aims to identify subgroups in which there appears to be a benefit of vitrectomy and subgroups in which vitrectomy does not appear to be beneficial and to obtain data that can be used to plan a randomized trial.

Subject will be followed through 2 years, with a primary outcome at 6 months post vitrectomy surgery. The vitrectomy procedure will be performed based on the investigators usual care and is not considered part of the research although the procedure performed will be collected.


Condition or disease
Diabetic Retinopathy Diabetic Macular Edema

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vitrectomy for Diabetic Macular Edema Study
Study Start Date : July 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort
Primary
Subjects vitreomacular traction, visual acuity 20/63 to 20/400, retinal thickness >300 microns in the central subfield on OCT, and cataract extraction not being performed in conjunction with vitrectomy.



Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: Baseline to 6 months ]
    Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.

  2. Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline [ Time Frame: Baseline to 6 Months ]
    Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.

  3. Percent of Participants With Change in Visual Acuity From Baseline to Six Months [ Time Frame: Baseline to 6 months ]
  4. Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months [ Time Frame: Baseline to 6 months ]
    Change in thickness is followup thickness minus baseline thickness.


Secondary Outcome Measures :
  1. Surgical Complications From Baseline to Six Months [ Time Frame: Baseline to 6 months ]
    Including intraoperative and perioperative medical complications. Same subject could have more than one complication



Information from the National Library of Medicine

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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
adults with diabetic macular edema
Criteria

Subject-level Inclusion Criteria

To be eligible, the following inclusion criteria (1-3) must be met:

  1. Age >= 18 years
  2. Diagnosis of diabetes mellitus (type 1 or type 2)
  3. Able and willing to provide informed consent.

    Subject-level Exclusion Criteria

    A patient is not eligible if any of the following exclusion criteria (4-6) are present:

  4. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
  5. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first year of the study.
  6. Blood pressure >180/110 (systolic above 180 OR diastolic above 110).

Study Eye Criteria

To be a study eye, all of the inclusion criteria (a-e) and none of the exclusion criteria (f-m) listed below must be met. A patient can have only one study eye. If both eyes are eligible and undergoing vitrectomy, the first eye having surgery will be the study eye.

The eligibility criteria for a study eye are as follows:

Inclusion

  1. Vitrectomy being performed as treatment for DME.
  2. E-ETDRS visual acuity 20/800 or better (E-ETDRS visual acuity score >= 3 letters).
  3. Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
  4. Presence of vitreomacular traction associated with macular edema OR edema is felt to be too diffuse to respond to focal or grid laser OR edema judged to be inadequately responsive to previous treatment(s) and unlikely to benefit from further focal photocoagulation.
  5. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.

    Exclusion

  6. Macular edema is considered to be due to a cause other than diabetic macular edema.
  7. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, subfoveal hard exudates, fibrous metaplasia, nonretinal condition).
  8. 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, post-surgical cystoid macular edema, etc.).
  9. History of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3.5 months prior to enrollment.
  10. History of peripheral scatter photocoagulation within 4 months prior to enrollment or anticipated need within the 4 months following enrollment.
  11. History of prior pars plana vitrectomy.
  12. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 6 months or anticipated within the next 6 months following enrollment.
  13. 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 ClinicalTrials.gov identifier (NCT number): NCT00709319


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92697
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States, 92354
Southern California Desert Retina Consultants, MC
Palm Springs, California, United States, 92262
West Coast Retina Medical Group, Inc.
San Francisco, California, United States, 94107
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
United States, Florida
University of Florida College of Med., Department of Ophthalmology
Jacksonville, Florida, United States, 32209
Florida Retina Consultants
Lakeland, Florida, United States, 33805
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Hawaii
Retina Consultants of Hawaii, Inc.
'Aiea, Hawaii, United States, 96701
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
John-Kenyon American Eye Institute
New Albany, Indiana, United States, 47150
United States, Kentucky
Paducah Retinal Center
Paducah, Kentucky, United States, 42001
United States, Maryland
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland, United States, 21287-9277
Retina Consultants of Delmarva, P.A.
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan, United States, 48202
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States, 49525
Associated Retina Consultants
Williamsburg, Michigan, United States, 49690
United States, Minnesota
Retina Center, PA
Minneapolis, Minnesota, United States, 55404
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Barnes Retina Institute
Saint Louis, Missouri, United States, 63110
United States, New York
Retina Consultants, PLLC
Slingerlands, New York, United States, 12159
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York, United States, 13224
United States, North Carolina
Charlotte Eye Ear Nose and Throat Assoc, PA
Charlotte, North Carolina, United States, 28210
Horizon Eye Care, PA
Charlotte, North Carolina, United States, 28211
United States, Ohio
Retina Associates of Cleveland, Inc.
Beachwood, Ohio, United States, 44122
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Retina Northwest, PC
Portland, Oregon, United States, 97210
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, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Southeastern Retina Associates, PC
Kingsport, Tennessee, United States, 37660
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37909
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
West Texas Retina Consultants P.A.
Abilene, Texas, United States, 79605
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
Valley Retina Institute
McAllen, Texas, United States, 78503
United States, Utah
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States, 84107
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Jaeb Center for Health Research
National Eye Institute (NEI)
Investigators
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Study Chair: Julia A. Haller, M.D. Wills Eye Institute
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00709319    
Other Study ID Numbers: NEI-125
U10EY018817-03 ( U.S. NIH Grant/Contract )
U10EY014229-07 ( U.S. NIH Grant/Contract )
U10EY014231-09 ( U.S. NIH Grant/Contract )
First Posted: July 3, 2008    Key Record Dates
Results First Posted: April 2, 2012
Last Update Posted: October 7, 2019
Last Verified: September 2019
Keywords provided by Jaeb Center for Health Research:
Diabetic retinopathy
Diabetic macular edema
dme
vitrectomy
Additional relevant MeSH terms:
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Macular Edema
Diabetic Retinopathy
Edema
Macular Degeneration
Diabetic Angiopathies
Retinal Diseases
Signs and Symptoms
Retinal Degeneration
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases