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Treatment of Epiretinal Membranes With Ranibizumab (LERM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238393
First Posted: November 10, 2010
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Queen's University
  Purpose
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.

Condition Intervention
Epiretinal Membrane Drug: intravitreal ranibizumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Evidence of improvement measured by optical coherence tomography [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures:
  • Distance visual acuity (ETDRS) [ Time Frame: 3 and 6 months ]
  • Near visual acuity (Snellen) [ Time Frame: 3 and 6 months ]
  • Subjective change in symptoms [ Time Frame: 3 and 6 months ]
  • Amsler grid improvement [ Time Frame: 3 and 6 months ]
  • Quality of life improvement [ Time Frame: 6 months ]

Enrollment: 11
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
('intravitreal ranibizumab' )
Drug: intravitreal ranibizumab
monthly injections x3 +/- 2nd series of 3
Other Name: Lucentis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238393


Locations
Canada, Ontario
Queen's University, Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Jeffrey Gale, MD Queen's University
  More Information

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT01238393     History of Changes
Other Study ID Numbers: OPTH-092-10
First Submitted: November 9, 2010
First Posted: November 10, 2010
Last Update Posted: January 13, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Epiretinal Membrane
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents