NCT03762226

Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema
• Macular Edema
• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Anti-VEGF	Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.

Timeline

• Start date: 2018-09-01
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2018-12-03
• Last updated: 2018-12-03

Locations

1 site across 1 country: Germany