- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358396
Glycemic Control and Diabetic Macular Edema
The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11431
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HBA1c
|
Correlate HBA1c with visual acuity outcome to therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity
Time Frame: 3 months
|
Correlate baseline HBA1c to the visual outcomes.
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Chrysarobin
Other Study ID Numbers
- HB-DME-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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