Diabetic Macular Edema Clinical Trial
Official title:
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Vitreo-Retinal Associates | Grand Rapids | Michigan |
Lead Sponsor | Collaborator |
---|---|
Vitreo-Retinal Associates, Michigan | Van Andel Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | End of study | No |
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