Treatment of Epiretinal Membranes With Ranibizumab

Epiretinal Membrane Clinical Trial

— LERM  

Official title:

A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238393
• Other study ID #: OPTH-092-10
• Status: Completed
• Phase: N/A
• First received: November 9, 2010
• Last updated: January 12, 2016
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: January 2016
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

Drug:
• intravitreal ranibizumab
monthly injections x3 +/- 2nd series of 3

Locations

Country	Name	City	State
Canada	Queen's University, Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of improvement measured by optical coherence tomography		3 and 6 months	No
Secondary	Distance visual acuity (ETDRS)		3 and 6 months	No
Secondary	Near visual acuity (Snellen)		3 and 6 months	No
Secondary	Subjective change in symptoms		3 and 6 months	No
Secondary	Amsler grid improvement		3 and 6 months	No
Secondary	Quality of life improvement		6 months	No