Back to resultsTreatment of Epiretinal Membranes With Ranibizumab (LERM)
Primary Purpose
Epiretinal Membrane
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
intravitreal ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane
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
Sites / Locations
- Queen's University, Hotel Dieu Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab
Arm Description
('intravitreal ranibizumab' )
Outcomes
Primary Outcome Measures
Evidence of improvement measured by optical coherence tomography
Secondary Outcome Measures
Distance visual acuity (ETDRS)
Near visual acuity (Snellen)
Subjective change in symptoms
Amsler grid improvement
Quality of life improvement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01238393
Brief Title
Treatment of Epiretinal Membranes With Ranibizumab
Acronym
LERM
Official Title
A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
('intravitreal ranibizumab' )
Intervention Type
Drug
Intervention Name(s)
intravitreal ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
monthly injections x3 +/- 2nd series of 3
Primary Outcome Measure Information:
Title
Evidence of improvement measured by optical coherence tomography
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Distance visual acuity (ETDRS)
Time Frame
3 and 6 months
Title
Near visual acuity (Snellen)
Time Frame
3 and 6 months
Title
Subjective change in symptoms
Time Frame
3 and 6 months
Title
Amsler grid improvement
Time Frame
3 and 6 months
Title
Quality of life improvement
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Gale, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University, Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treatment of Epiretinal Membranes With Ranibizumab
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