NCT01358396

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
Last Updated

May 23, 2011

Status Verified

January 1, 2010

Enrollment Period

6 months

First QC Date

May 19, 2011

Last Update Submit

May 20, 2011

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, Glycemic Control

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Correlate baseline HBA1c to the visual outcomes.

    3 months

Study Arms (1)

HBA1c

Other: Respond to therapy for diabetic macular edema

Interventions

Respond to therapy for diabetic macular edemaOTHER

Correlate HBA1c with visual acuity outcome to therapy.

Also known as: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin
HBA1c

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic patients with macular edema with central foveal thickness more than 250 microns and no proliferative changes.

You may qualify if:

  • Central foveal thickness more than 250 microns

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Cairo Governorate, 11431, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 23, 2011

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

October 1, 2010

Last Updated

May 23, 2011

Record last verified: 2010-01

Locations

EG(1)