Diabetic Macular EdemaNCT01358396
Glycemic Control and Diabetic Macular Edema
An observational study of Diabetic Macular Edema, run by Cairo University at 1 site in Egypt.
Trial summary
Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Respond to therapy for diabetic macular edema
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic patients with macular edema with central foveal thickness more than 250 microns and no proliferative changes.
Who may be able to join
- Central foveal thickness more than 250 microns
Who cannot join
- Proliferative Diabetic Retinopathy.
- Traction Macular Membranes
- Previous Laser or intravitreal injections within 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.
Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.
Read the 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%.
- Conditions
- Diabetic Macular Edema
- Being tested
- Respond to therapy for diabetic macular edema
- Keywords
- Diabetic Macular Edema, Glycemic Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respond to therapy for diabetic macular edemaOther
Also called Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin
Correlate HBA1c with visual acuity outcome to therapy.
| Study group | Role | What they receive |
|---|---|---|
| HBA1c | Not described Receives: Other: Respond to therapy for diabetic macular edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Correlate baseline HBA1c to the visual outcomes.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358396
- Sponsor's protocol ID
- HB-DME-1
- Status last verified
- Jan 2010
- First submitted
- 19 May 2011
- Last updated
- 23 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.
- ClinicalTrials.gov ID
- NCT01358396
- Acronym / sponsor ID
- HB-DME-1
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema, Glycemic Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBA1c | – | Other: Respond to therapy for diabetic macular edema |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic patients with macular edema with central foveal thickness more than 250 microns and no proliferative changes.
Key inclusion criteria (1 listed)
- Central foveal thickness more than 250 microns
Key exclusion criteria (3 listed)
- Proliferative Diabetic Retinopathy.
- Traction Macular Membranes
- Previous Laser or intravitreal injections within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respond to therapy for diabetic macular edemaAlso: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobinCorrelate HBA1c with visual acuity outcome to therapy. | Other | HBA1c |
Primary outcome
Visual Acuity
Time frame: 3 months
Correlate baseline HBA1c to the visual outcomes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2011.