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Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

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ClinicalTrials.gov Identifier: NCT01473251
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
Van Andel Research Institute
Information provided by (Responsible Party):
Vitreo-Retinal Associates, Michigan

Brief Summary:
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

Condition or disease Intervention/treatment Phase
Exudative Macular Degeneration Diabetic Macular Edema Drug: Avastin Drug: Lucentis Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Study Start Date : November 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Avastin for Diabetic Macular Edema
1.25 mg avastin monthly for 4 months
Drug: Avastin
1.25 mg monthly for 4 months
Active Comparator: Avastin for Exudative Macular Degeneration
1.25 mg Avastin monthly for 4 months
Drug: Avastin
1.25 mg monthly for 4 months
Active Comparator: Lucentis for Exudative Macular Degeneration
0.5 mg Lucentis monthly for 4 months
Drug: Lucentis
0.5 mg monthly for 4 months



Primary Outcome Measures :
  1. Analysis of collected vitreous samples to identify biomarkers. [ Time Frame: End of study ]
    Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration.
  • Diabetic macular edema with average retinal thickness central subfield >/= 290um.

Exclusion Criteria:

  • Macular atrophy/fibrosis.
  • Ocular anti-VEGF treatment within 3 months.
  • Treatment with topical or oral carbonic-anhydrase inhibitor within one month
  • Laser photocoagulation within 3 months (diabetic cohort)

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): NCT01473251


Locations
United States, Michigan
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States, 49525
Sponsors and Collaborators
Vitreo-Retinal Associates, Michigan
Van Andel Research Institute
Investigators
Principal Investigator: Louis C. Glazer, MD Vitreo Retinal Associates

Responsible Party: Vitreo-Retinal Associates, Michigan
ClinicalTrials.gov Identifier: NCT01473251     History of Changes
Other Study ID Numbers: VARI 2011 002
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Edema
Macular Degeneration
Macular Edema
Wet Macular Degeneration
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mitogens
Bevacizumab
Ranibizumab
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors