Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
NCT ID: NCT03762226
Last Updated: 2018-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2018-09-01
2021-12-31
Brief Summary
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Detailed Description
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At baseline patients underwent an extensive ophthalmological examination (best-corrected visual acuity, OCT, OCT-angiography, fluorescein angiography, fundus photography). Besides that, systemic work-up (including 24h blood pressure measurement, electrocardiogram, and serological blood testing) is conducted.
Patients underwent routine ME treatment including at least 4 monthly anti-VEGF injections, as first-line therapy. Further injections will be conducted if needed. Re-treatment criteria are: persistent intra- and/or subretinal fluid seen on SD-OCT, central subfield thickness \> 300 µm. Ophthalmological examination will be repeated at month 3, 6 and month 12. Systemic work-up will be repeated at month 6.
Primary outcome is the correlation of systemic parameters with functional and anatomical response at month 6. Secondary outcome is the correlation of systemic parameters with functional and anatomical response at month 12.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with Macular edema
Patients with clinically significant macular edema due to diabetes or retinal vein occlusion, undergoing at least 4 monthly intravitreal anti-VEGF injections.
Anti-VEGF
Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.
Interventions
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Anti-VEGF
Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of diabetes mellitus (type 1 or type 2) and/or retinal vein occlusion
3. macular edema causing visual loss, with study eye VA of 0.1 - 1.0 logMAR (20/25 - 20/200 Snellen equivalent)
4. 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
5. last intravitreal treatment \> 3 months ago.
Exclusion Criteria
2. any concomitant ocular or neurological condition that could affect Vision except of cataract.
3. pregnancy.
18 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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PD Dr. habil. Matus Rehak
Prof. MUDr. Matus Rehak
Principal Investigators
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Matus Rehak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Leipzig, Department of Ophthalmology
Locations
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University Hospital Leipzig, department of ophthalmology
Leipzig, Saxony, Germany
Countries
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Central Contacts
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Other Identifiers
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72311607
Identifier Type: -
Identifier Source: org_study_id
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