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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Vitreo-Retinal Associates, Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Van Andel Research Institute
Information provided by (Responsible Party):
Vitreo-Retinal Associates, Michigan
ClinicalTrials.gov Identifier:
NCT01473251
First received: November 14, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Exudative Macular Degeneration
Diabetic Macular Edema
Drug: Avastin
Drug: Lucentis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vitreo-Retinal Associates, Michigan:

Primary Outcome Measures:
  • Analysis of collected vitreous samples to identify biomarkers. [ Time Frame: End of study ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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)
  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: NCT01473251

Locations
United States, Michigan
Vitreo-Retinal Associates Recruiting
Grand Rapids, Michigan, United States, 49525
Contact: Louis C. Glazer, M.D.    616-285-1200      
Principal Investigator: Louis C. Glazer, M.D.         
Sponsors and Collaborators
Vitreo-Retinal Associates, Michigan
Van Andel Research Institute
  More Information

No publications provided

Responsible Party: Vitreo-Retinal Associates, Michigan
ClinicalTrials.gov Identifier: NCT01473251     History of Changes
Other Study ID Numbers: VARI 2011 002
Study First Received: November 14, 2011
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014