Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

Study Overview
=================
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.

Official Title
-----------------
Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

Conditions
-----------------
Diabetic Macular Edema, Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Anti-VEGF


Participation Criteria
=================
Eligibility Criteria
-----------------
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 µm 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with Macular edema<br>Patients with clinically significant macular edema due to diabetes or retinal vein occlusion, undergoing at least 4 monthly intravitreal anti-VEGF injections. | Drug: Anti-VEGF<br>* Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.<br>* Other names: Intravitreal anti-VEGF injection;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |