Evaluation of Vitrectomy for Diabetic Macular Edema

NCT00709319 | Completed Results

• 4 other identifiers: NEI-125U10EY018817-03U10EY014229-07U10EY014231-09
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 48

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Keywords

Diabetic retinopathy; Diabetic macular edema; dme; vitrectomy

Outcome Measures

Primary Outcomes (4)

• Visual Acuity

  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.

  Baseline to 6 months

• Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline

  Change in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.

  Baseline to 6 Months

• Percent of Participants With Change in Visual Acuity From Baseline to Six Months

  Baseline to 6 months

• Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months

  Change in thickness is followup thickness minus baseline thickness.

  Baseline to 6 months

Secondary Outcomes (1)

• Surgical Complications From Baseline to Six Months

  Baseline to 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with diabetic macular edema

You may qualify if:

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

You may not qualify if:

• 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).
• 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.
• Blood pressure \>180/110 (systolic above 180 OR diastolic above 110).
• Study Eye Criteria
• The eligibility criteria for a study eye are as follows:
• Vitrectomy being performed as treatment for DME.
• E-ETDRS visual acuity 20/800 or better (E-ETDRS visual acuity score \>= 3 letters).
• Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
• 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.
• Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
• 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 would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, subfoveal hard exudates, fibrous metaplasia, 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, post-surgical cystoid macular edema, etc.).
• History of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3.5 months prior to enrollment.
• History of peripheral scatter photocoagulation within 4 months prior to enrollment or anticipated need within the 4 months following enrollment.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Sites (48)

University of California, Irvine

Irvine, California, 92697, United States

Location

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, 92354, United States

Location

Southern California Desert Retina Consultants, MC

Palm Springs, California, 92262, United States

Location

West Coast Retina Medical Group, Inc.

San Francisco, California, 94107, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

University of Florida College of Med., Department of Ophthalmology

Jacksonville, Florida, 32209, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Retina Associates of Hawaii, Inc.

Honolulu, Hawaii, 96813, United States

Location

Retina Consultants of Hawaii, Inc.

‘Aiea, Hawaii, 96701, United States

Location

Raj K. Maturi, M.D., P.C.

Indianapolis, Indiana, 46290, United States

Location

John-Kenyon American Eye Institute

New Albany, Indiana, 47150, United States

Location

Paducah Retinal Center

Paducah, Kentucky, 42001, United States

Location

Elman Retina Group, P.A.

Baltimore, Maryland, 21237, United States

Location

Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, 21287-9277, United States

Location

Retina Consultants of Delmarva, P.A.

Salisbury, Maryland, 21801, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

Detroit, Michigan, 48202, United States

Location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49525, United States

Location

Associated Retina Consultants

Williamsburg, Michigan, 49690, United States

Location

Retina Center, PA

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Barnes Retina Institute

St Louis, Missouri, 63110, United States

Location

Retina Consultants, PLLC

Slingerlands, New York, 12159, United States

Location

Retina-Vitreous Surgeons of Central New York, PC

Syracuse, New York, 13224, United States

Location

Charlotte Eye Ear Nose and Throat Assoc, PA

Charlotte, North Carolina, 28210, United States

Location

Horizon Eye Care, PA

Charlotte, North Carolina, 28211, United States

Location

Retina Associates of Cleveland, Inc.

Beachwood, Ohio, 44122, United States

Location

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Retina Northwest, PC

Portland, Oregon, 97210, United States

Location

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Palmetto Retina Center

Columbia, South Carolina, 29169, United States

Location

Carolina Retina Center

Columbia, South Carolina, 29223, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates, PC

Kingsport, Tennessee, 37660, United States

Location

Southeastern Retina Associates, P.C.

Knoxville, Tennessee, 37909, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

West Texas Retina Consultants P.A.

Abilene, Texas, 79605, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Charles A. Garcia, PA & Associates

Houston, Texas, 77002, United States

Location

Retina and Vitreous of Texas

Houston, Texas, 77025, United States

Location

Texas Retina Associates

Lubbock, Texas, 79424, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Rocky Mountain Retina Consultants

Salt Lake City, Utah, 84107, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• Diabetic Retinopathy Clinical Research Network Writing Committee; Haller JA, Qin H, Apte RS, Beck RR, Bressler NM, Browning DJ, Danis RP, Glassman AR, Googe JM, Kollman C, Lauer AK, Peters MA, Stockman ME. Vitrectomy outcomes in eyes with diabetic macular edema and vitreomacular traction. Ophthalmology. 2010 Jun;117(6):1087-1093.e3. doi: 10.1016/j.ophtha.2009.10.040. Epub 2010 Mar 17.

  PMID: 20299105 BACKGROUND

• Flaxel CJ, Edwards AR, Aiello LP, Arrigg PG, Beck RW, Bressler NM, Bressler SB, Ferris FL 3rd, Gupta SK, Haller JA, Lazarus HS, Qin H. Factors associated with visual acuity outcomes after vitrectomy for diabetic macular edema: diabetic retinopathy clinical research network. Retina. 2010 Oct;30(9):1488-95. doi: 10.1097/IAE.0b013e3181e7974f.

  PMID: 20924264 BACKGROUND

• Gangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.

  PMID: 21571677 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Adam R. Glassman, Director DRCR.net Coordinating Center
• Organization: Jaeb Center for Health Research

drcrstat3@jaeb.org

813-975-8690

Study Officials

• Julia A. Haller, M.D.

  Wills Eye Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: July 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: February 1, 2009
• Last Updated: October 7, 2019
• Results First Posted: April 2, 2012

Record last verified: 2019-09

Locations

US (48)