Clinical trial NCT03762226: Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
Official title: Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Macular Edema
Retinal Vein Occlusion
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with macular edema due to Diabetes or retinal vein occlusion

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 to diabetes or retinal vein occlusion.

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-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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation of systemic factors on functional and anatomical outcome at month 6.
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of systemic factors on functional and anatomical outcome at month 12.
timeFrame: 12 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University Hospital Leipzig, department of ophthalmology
state: Saxony
Study officials:
affiliation: University Hospital Leipzig, Department of Ophthalmology
name: Matus Rehak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: