Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

NCT03762226 | Unknown

• 1 other identifier: 72311607
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema; Macular Edema; Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of systemic factors on functional and anatomical outcome at month 12.

  12 months

Study Arms (1)

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

Interventions

Anti-VEGF DRUG

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

Also known as: Intravitreal anti-VEGF injection

Patient with Macular edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (1)

University Hospital Leipzig, department of ophthalmology

Leipzig, Saxony, 04103, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and heparine blood sample.

MeSH Terms

Conditions

Macular Edema; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matus Rehak, MD, PhD

  University Hospital Leipzig, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matus Rehak, MD, PhD

CONTACT

+493419721650; matus.rehak@medizin.uni-leipzig.de

Catharina Busch, MD

CONTACT

+493419721650; catharina.busch@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MUDr. Matus Rehak

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: December 3, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)