Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    100
  • sponsor
    University of Leipzig
Updated on 22 January 2021
diabetes
edema
vegf
bevacizumab
vascular endothelial growth factor
macular edema
venous occlusion
retinal vein occlusion
diabetic macular edema
anti-vegf therapy
optical coherence tomography
spectral domain optical coherence tomography
visual loss

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 to diabetes or retinal vein occlusion.

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-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 m. 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.

Details
Condition Venous Thrombosis, Vascular Diseases, Macular Edema, age-related macular degeneration, Retinal Vein Occlusion, Diabetic Macular Edema, Cystoid Macular Edema, Macular Degeneration, Deep Vein Thrombosis
Treatment Anti-VEGF
Clinical Study IdentifierNCT03762226
SponsorUniversity of Leipzig
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 m in the central subfield thickness (CST) with intra +/- subretinal fluid seen on spectral domain optical coherence tomography
last intravitreal treatment > 3 months ago

Exclusion Criteria

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
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