Treatment of Epiretinal Membranes With Ranibizumab | NCT01238393

Studies
Treatment of Epiretinal Membranes With Ranibizumab

NCT01238393

Sponsor

Queen's University

Status

Completed

Last Update Posted

Jan 13, 2016Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

intravitreal ranibizumab

Countries

Canada

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

Jan 2016

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

Nov 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Nov 9, 2010

First Submission Date that Met QC Criteria

Nov 9, 2010

First Posted Date

Nov 10, 2010Estimated

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

Jan 12, 2016

Last Update Posted Date

Jan 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is to determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranibizumab	Experimental	('intravitreal ranibizumab' )	Drug: intravitreal ranibizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravitreal ranibizumab	Drug	monthly injections x3 +/- 2nd series of 3	Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of improvement measured by optical coherence tomography		3 and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Distance visual acuity (ETDRS)		3 and 6 months
Near visual acuity (Snellen)		3 and 6 months
Subjective change in symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic idiopathic epiretinal membrane

Exclusion Criteria:

vision worse than 6/18 and fit for surgery
prior vitreoretinal surgery or injection
diabetes
any past or current form of retinal vein occlusion or neovascularization
age-related macular degeneration
other condition causing significant limitation of visual potential

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Gale, MD	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen's University, Hotel Dieu Hospital		Kingston	Ontario	K7L 5G2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided