Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

University of Leipzig100 enrolled

Overview

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 to diabetes or retinal vein occlusion.

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-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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Diabetic Macular Edema Macular Edema Retinal Vein Occlusion

Interventions

Anti-VEGFDRUG

Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>= 18 years 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: 1. concomitant ocular disease that could cause macular edema (including choroidal neovascularization from any cause, uveitis or intraocular surgery less than 6 months ago). 2. any concomitant ocular or neurological condition that could affect Vision except of cataract. 3. pregnancy.

Locations (1)

University Hospital Leipzig, department of ophthalmology

Leipzig, Saxony, Germany

RECRUITING

Outcomes

Primary Outcomes

Correlation of systemic factors on functional and anatomical outcome at month 6.

Correlation between blood pressure and serological Parameters at baseline and visual acuity/central subfield thickness at month 6.

Time frame: 6 months

Secondary Outcomes

Correlation of systemic factors on functional and anatomical outcome at month 12.

Correlation between blood pressure and serological parameters at baseline and visual acuity/central subfield thickness at month 12.

Time frame: 12 months

Central Contacts

Matus Rehak, MD, PhD

CONTACT

+493419721650 matus.rehak@medizin.uni-leipzig.de

Catharina Busch, MD

CONTACT

+493419721650 catharina.busch@medizin.uni-leipzig.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.