Glycemic Control and Diabetic Macular Edema

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: NCT01358396
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : May 23, 2011
Information provided by:
Cairo University

Brief Summary:
Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.

Condition or disease Intervention/treatment
Diabetic Macular Edema Other: Respond to therapy for diabetic macular edema

Detailed Description:

To evaluate the visual and anatomical response to therapy in patients with diabetic macular edema (DME) in relation to their glycemic control.

Patients with DME with central foveal thickness (CFT) > 250µm with no proliferative disease had their glycosolated hemoglobin (HbA1c) measured at baseline and 3 months. CFT by optical coherence tomography, and best corrected visual acuity (BCVA) in logMARs were measured at baseline, 1, and 3 months. Exclusion criteria: laser or intravitreal injections within 6 months, hard exudates within 500um of the foveal center, or macular traction. Therapy included laser and intravitreal anti VEGFs. HbA1c graded as: G1=<7%, G2= 7-7.9%, G3= 8-8.9%, G4 = >9%; and as: low <8%, high ≥ 8%.

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Group/Cohort Intervention/treatment
HBA1c Other: Respond to therapy for diabetic macular edema
Correlate HBA1c with visual acuity outcome to therapy.
Other Name: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin

Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 3 months ]
    Correlate baseline HBA1c to the visual outcomes.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetic patients with macular edema with central foveal thickness more than 250 microns and no proliferative changes.

Inclusion Criteria:

  • Central foveal thickness more than 250 microns

Exclusion Criteria:

  • Proliferative Diabetic Retinopathy.
  • Traction Macular Membranes
  • Previous Laser or intravitreal injections within 6 months.

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): NCT01358396

Cairo University
Cairo, Egypt, 11431
Sponsors and Collaborators
Cairo University

Responsible Party: Tamer A Macky, Cario University Identifier: NCT01358396     History of Changes
Other Study ID Numbers: HB-DME-1
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: May 23, 2011
Last Verified: January 2010

Keywords provided by Cairo University:
Diabetic Macular Edema, Glycemic Control

Additional relevant MeSH terms:
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases