Status:
UNKNOWN
Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
Lead Sponsor:
University of Leipzig
Conditions:
Diabetic Macular Edema
Macular Edema
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to evaluate the influence and prognostic value of systemic factors (such as the cardiovascular and metabolic status) on the treatment response to anti-VEGF therapy in macular edema due...
Detailed Description
This study includes patients with macular edema (ME) due to diabetes or retinal vein occlusion in the need of treatment. At baseline patients underwent an extensive ophthalmological examination (best...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2) and/or retinal vein occlusion
- macular edema causing visual loss, with study eye VA of 0.1 - 1.0 logMAR (20/25 - 20/200 Snellen equivalent)
- macular edema defined clinically and by retinal thickness of \> 300 µm in the central subfield thickness (CST) with intra +/- subretinal fluid seen on spectral domain optical coherence tomography
- last intravitreal treatment \> 3 months ago.
Exclusion
- concomitant ocular disease that could cause macular edema (including choroidal neovascularization from any cause, uveitis or intraocular surgery less than 6 months ago).
- any concomitant ocular or neurological condition that could affect Vision except of cataract.
- pregnancy.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03762226
Start Date
September 1 2018
End Date
December 31 2021
Last Update
December 3 2018
Active Locations (1)
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1
University Hospital Leipzig, department of ophthalmology
Leipzig, Saxony, Germany, 04103