Back to resultsAnalysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Primary Purpose
Exudative Macular Degeneration, Diabetic Macular Edema
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avastin
Avastin
Lucentis
Sponsored by
About this trial
This is an interventional health services research trial for Exudative Macular Degeneration
Eligibility 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)
Sites / Locations
- Vitreo-Retinal Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Avastin for Diabetic Macular Edema
Avastin for Exudative Macular Degeneration
Lucentis for Exudative Macular Degeneration
Arm Description
1.25 mg avastin monthly for 4 months
1.25 mg Avastin monthly for 4 months
0.5 mg Lucentis monthly for 4 months
Outcomes
Primary Outcome Measures
Analysis of collected vitreous samples to identify biomarkers.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01473251
First Posted
November 14, 2011
Last Updated
December 16, 2014
Sponsor
Vitreo-Retinal Associates, Michigan
Collaborators
Van Andel Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01473251
Brief Title
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Official Title
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitreo-Retinal Associates, Michigan
Collaborators
Van Andel Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Macular Degeneration, Diabetic Macular Edema
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avastin for Diabetic Macular Edema
Arm Type
Active Comparator
Arm Description
1.25 mg avastin monthly for 4 months
Arm Title
Avastin for Exudative Macular Degeneration
Arm Type
Active Comparator
Arm Description
1.25 mg Avastin monthly for 4 months
Arm Title
Lucentis for Exudative Macular Degeneration
Arm Type
Active Comparator
Arm Description
0.5 mg Lucentis monthly for 4 months
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
1.25 mg monthly for 4 months
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
1.25 mg monthly for 4 months
Intervention Type
Drug
Intervention Name(s)
Lucentis
Intervention Description
0.5 mg monthly for 4 months
Primary Outcome Measure Information:
Title
Analysis of collected vitreous samples to identify biomarkers.
Description
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.
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis C. Glazer, MD
Organizational Affiliation
Vitreo Retinal Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
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