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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

  • Drug: Avastin
    • 1.25 mg monthly for 4 months
  • Drug: Avastin
    • 1.25 mg monthly for 4 months
  • Drug: Lucentis
    • 0.5 mg monthly for 4 months

Arms, Groups and Cohorts

  • Active Comparator: Avastin for Diabetic Macular Edema
    • 1.25 mg avastin monthly for 4 months
  • Active Comparator: Avastin for Exudative Macular Degeneration
    • 1.25 mg Avastin monthly for 4 months
  • Active Comparator: Lucentis for Exudative Macular Degeneration
    • 0.5 mg Lucentis monthly for 4 months

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vitreo-Retinal Associates, Michigan
  • Collaborator
    • Van Andel Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Louis C. Glazer, MD, Principal Investigator, Vitreo Retinal Associates

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