Glycemic Control and Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358396
• Other study ID #: HB-DME-1
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2011
• Last updated: May 20, 2011
• Start date: January 2010
• Est. completion date: October 2010

Study information

• Verified date: January 2010
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: EGYPT:Faculty of Medicine, Research Committee,Cairo University
• Study type: Observational

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Other:
• Respond to therapy for diabetic macular edema
Correlate HBA1c with visual acuity outcome to therapy.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Correlate baseline HBA1c to the visual outcomes.	3 months	No