Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
This study is currently recruiting participants.
Verified June 2012 by Vitreo-Retinal Associates, Michigan
Sponsor:
Vitreo-Retinal Associates, Michigan
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
U.S. FDA Resources
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
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 Signs and Symptoms Retinal Degeneration Retinal Diseases Eye Diseases Mitogens Bevacizumab |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013