Influence of Systemic Parameters in Diabetic Macular Edem... | NCT03762226

Studies
Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study

NCT03762226

Sponsor

University of Leipzig

Status

Unknown status

Last Update Posted

Dec 3, 2018Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Diabetic Macular Edema
Macular Edema
Retinal Vein Occlusion

Interventions

Anti-VEGF

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Nov 30, 2018

First Submission Date that Met QC Criteria

Nov 30, 2018

First Posted Date

Dec 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2018

Last Update Posted Date

Dec 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Anti-VEGF	Drug	Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.	Patient with Macular edema

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matus Rehak, MD, PhD	Contact	+493419721650		matus.rehak@medizin.uni-leipzig.de
Catharina Busch, MD	Contact	+493419721650		catharina.busch@medizin.uni-leipzig.de

Overall Officials

Name	Affiliation	Role
Matus Rehak, MD, PhD	University Hospital Leipzig, Department of Ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Leipzig, department of ophthalmology	Recruiting	Leipzig	Saxony	04103	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema
D012170	Retinal Vein Occlusion

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided