Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Macular Edema; Macular Edema; Retinal Vein Occlusion
• Intervention / Treatment: Drug: Anti-VEGF

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Recruiting
      • University Hospital Leipzig, department of ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with macular edema due to Diabetes or retinal vein occlusion

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with Macular edema; 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; Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.; 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

Collaborators and Investigators

• Sponsor: University of Leipzig
• Investigators: Principal Investigator: Matus Rehak, MD, PhD, University Hospital Leipzig, department of ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): December 3, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema
• Other Study ID Numbers: 72311607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No