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Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

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.
 
ClinicalTrials.gov Identifier: NCT03097068
Recruitment Status : Unknown
Verified May 2017 by Louis C. Glazer, MD, Vitreo-Retinal Associates, Michigan.
Recruitment status was:  Recruiting
First Posted : March 31, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Genentech, Inc.
Michigan State University
Information provided by (Responsible Party):
Louis C. Glazer, MD, Vitreo-Retinal Associates, Michigan

Brief Summary:
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Lucentis Phase 4

Detailed Description:
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Actual Study Start Date : April 19, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab


Intervention Details:
  • Drug: Lucentis
    0.3mg Lucetnis


Primary Outcome Measures :
  1. vascular endothelial growth factor levels [ Time Frame: One year ]
    In aqueous



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of diabetes mellitus
  • Best corrected visual acuity 20/32 - 20/320
  • Diabetic macular edema involving the center of the macula
  • Optical coherence tomography central subfield thickness of at least 250 microns

Exclusion Criteria:

  • History of anti-vascular endothelial growth factor treatment in the past 12 months
  • Any diabetic macular edema treatment in the past 4 months
  • Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months

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): NCT03097068


Locations
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United States, Michigan
Vitreo-Retinal Associates Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Louis C. Glazer, M.D.    616-285-1200    research@vrapc.com   
Principal Investigator: Louis C. Glazer, M.D.         
Sponsors and Collaborators
Louis C. Glazer, MD
Genentech, Inc.
Michigan State University

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Responsible Party: Louis C. Glazer, MD, Principal Investigator, Vitreo-Retinal Associates, Michigan
ClinicalTrials.gov Identifier: NCT03097068    
Other Study ID Numbers: ML39638
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents