Vitrous Analysis in Proliferative Diabetic Retinopathy | NCT01478763

Studies
Vitrous Analysis in Proliferative Diabetic Retinopathy

NCT01478763

Sponsor

Anders Kvanta

Status

Completed

Last Update Posted

Sep 25, 2014Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Proliferative Diabetic Retinopathy

Interventions

Not provided

Countries

Sweden

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 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Nov 21, 2011

First Submission Date that Met QC Criteria

Nov 22, 2011

First Posted Date

Nov 23, 2011Estimated

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 24, 2014

Last Update Posted Date

Sep 25, 2014Estimated

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

Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy

Detailed Description

To analyse and compare vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

proliferative diabetic retinopathy with vitreous hemorrhage

Exclusion Criteria:

vitreous hemorrhage of other cause than proliferative diabetic retinopathy
previous vitrectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Kvanta, PhD	St. Erik Eye Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Erik Eye Hospital		Stockholm	NonUS	11282	Sweden