Status:
UNKNOWN
Microperimetry and Optical Coherence Tomography (OCT) With Lucentis for Diabetic Macular Edema (DME)
Lead Sponsor:
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
51+ years
Phase:
PHASE2
PHASE3
Brief Summary
Diabetic maculopathy is the leading cause of visual impairment in the working-age population in developed countries. Diabetic macular edema can cause impaired visual acuity and so far is treated by la...
Detailed Description
Diabetic maculopathy due to diabetic macular edema (DME) is the leading cause of visual impairment in the working-age population in developed countries. DME is the swelling of the retina resulting fro...
Eligibility Criteria
Inclusion
- Study eye with clinically significant macular edema, for which one of the following characteristics has to be present:
- retinal thickening at or within 500µm from the center of the macula,
- hard exudates at or within 500µm from the center of the macula associated with thickening of the adjacent retina,
- a zone (\>1-disk area) or zones of retinal thickening of which any part is within 1 disk diameter from the center of the macula.
- Second line treatment after ineffective laser treatment
- Men or women with diabetes mellitus
- Only one eye per patient
- Age \> 50 years
- HbA1c \< 8%
Exclusion
- Study eye with concomitant retinal or choroidal disorder other than diabetic retinopathy
- Study eye with significant central lens opacities and / or conditions that limit the view of the fundus
- poor general condition
- woman of childbearing potential, current pregnancy or breastfeeding
- Patients who are unwilling to adhere to visit examination schedules
- Evidence of macular traction or taut posterior hyloid.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00885794
Start Date
May 1 2008
End Date
May 1 2012
Last Update
June 27 2011
Active Locations (1)
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1
Rudolf Foundation Clinic
Vienna, Vienna, Austria, 1030