Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

Diabetic Macular Edema Clinical Trial

Official title:

Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03762226
• Other study ID #: 72311607
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2018
• Source: University of Leipzig
• Contact: Matus Rehak, MD, PhD
• Phone: +493419721650
• Email: matus.rehak[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Leipzig, department of ophthalmology	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	12 months