NCT01238393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

November 9, 2010

Last Update Submit

January 12, 2016

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (1)

  • Evidence of improvement measured by optical coherence tomography

    3 and 6 months

Secondary Outcomes (5)

  • Distance visual acuity (ETDRS)

    3 and 6 months

  • Near visual acuity (Snellen)

    3 and 6 months

  • Subjective change in symptoms

    3 and 6 months

  • Amsler grid improvement

    3 and 6 months

  • Quality of life improvement

    6 months

Study Arms (1)

Ranibizumab

EXPERIMENTAL

('intravitreal ranibizumab' )

Drug: intravitreal ranibizumab

Interventions

intravitreal ranibizumabDRUG

monthly injections x3 +/- 2nd series of 3

Also known as: Lucentis
Ranibizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic idiopathic epiretinal membrane

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University, Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Conditions

Epiretinal Membrane

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jeffrey Gale, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 10, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

CA(1)