Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedDecember 17, 2014
December 1, 2014
2.4 years
November 14, 2011
December 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Avastin for Diabetic Macular Edema
ACTIVE COMPARATOR1.25 mg avastin monthly for 4 months
Avastin for Exudative Macular Degeneration
ACTIVE COMPARATOR1.25 mg Avastin monthly for 4 months
Lucentis for Exudative Macular Degeneration
ACTIVE COMPARATOR0.5 mg Lucentis monthly for 4 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vitreo-Retinal Associates, Michiganlead
- Van Andel Research Institutecollaborator
Study Sites (1)
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louis C. Glazer, MD
Vitreo Retinal Associates
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 17, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 17, 2014
Record last verified: 2014-12