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Monoclonal Antibodies
Group 5 Avastin 6 weeks for Age-Related Macular Degeneration
Phase 2 & 3
Waitlist Available
Led By Ronald E Frenkel, MD
Research Sponsored by East Florida Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.
Eligible Conditions
- Age-Related Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Secondary outcome measures
Amount of fluid (cubic mm) as measured by Ocular Coherence Tomography in the contralateral eye will be correlated with systemic Vascular Endothelial Growth Factor levels
Change in Serum drug levels in nanomoles (nM) units following treatment
Trial Design
10Treatment groups
Active Control
Group I: Group 5 Avastin 6 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Group II: Group 10 Control Group no treatmentActive Control1 Intervention
Blood samples will be collected from patients who are not receiving anti-VEGF treatment.
Group III: Group 7 Lucentis 8 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Group IV: Group 3 Eylea 4 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Group V: Group 4 Lucentis 6 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Group VI: Group 1 Lucentis 4 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Group VII: Group 8 Avastin 8 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Group VIII: Group 2 Avastin 4 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Group IX: Group 9 Eylea 8 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Group X: Group 6 Eylea 6 weeksActive Control1 Intervention
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
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Who is running the clinical trial?
East Florida Eye InstituteLead Sponsor
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,819 Total Patients Enrolled
Ronald E Frenkel, MDPrincipal InvestigatorEast Florida Eye Institute
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