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Treatment of Epiretinal Membranes With Ranibizumab (LERM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT01238393
First received: November 9, 2010
Last updated: July 31, 2012
Last verified: July 2012
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distance visual acuity (ETDRS) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Near visual acuity (Snellen) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Subjective change in symptoms [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Amsler grid improvement [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Quality of life improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 Drug: intravitreal ranibizumab
monthly injections x3 +/- 2nd series of 3
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT01238393     History of Changes
Other Study ID Numbers: OPTH-092-10
Study First Received: November 9, 2010
Last Updated: July 31, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Epiretinal Membrane
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014