Gene Expression in Patients With Epiretinal Membranes | NCT01946451

Studies
Gene Expression in Patients With Epiretinal Membranes

NCT01946451

Sponsor

Medical University of Silesia

Status

Unknown status

Last Update Posted

Sep 19, 2013Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Proliferative Diabetic Retinopathy

Interventions

Not provided

Countries

Poland

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

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2013Estimated

First Submitted Date

Sep 16, 2013

First Submission Date that Met QC Criteria

Sep 18, 2013

First Posted Date

Sep 19, 2013Estimated

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

Sep 18, 2013

Last Update Posted Date

Sep 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study was to investigate the expression of selected genes both in epiretinal membranes (ERMs) and peripheral blood mononuclear cells (PBMCs) from patients with primary and secondary epiretinal membranes in proliferative diabetic retinopathy. Possible correlations between messenger ribonucleic acid (mRNA) levels of these genes were also identified.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gene expression in patients with idiopathic and secondary epiretinal membranes in proliferative diabetic retinopathy.		The period between the diagnosis of the ERMs and the actual surgery for the condition was between 2 and 43 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian race,
both males and females,
aged ≥ 55 years,
suffering from idiopathic ERMs or secondary ERMs in proliferative diabetic retinopathy (PDR).
Presence of ERM was proven in optical coherence tomography (OCT) examination.

Exclusion criteria:

aged < 55 years,
systemic connective tissue disease,
active inflammatory process

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study population description:

The blood and ERM samples were obtained from patients treated in the Department of Ophthalmology, University Hospital No. 5, Medical University of Silesia, Katowice, Poland.

All subjects underwent a complete ophthalmic examination: best corrected visual acuity (BCVA), tonometry, slit lamp examination of anterior and posterior segment, optical coherence tomography (OCT) of the central retina.

Sampling Method

Non-Probability Sample

Label	Type	Description	Intervention Names
Idiophatic ERMs
Secondary ERMs