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Monoclonal Antibodies
Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
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
All Individual Drugs Already Approved
No Placebo-Only Group
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Secondary study objectives
Change in Serum drug levels in nanomoles (nM) units following treatment
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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.
Find a Location
Who is running the clinical trial?
East Florida Eye InstituteLead Sponsor
Genentech, Inc.Industry Sponsor
1,564 Previous Clinical Trials
570,152 Total Patients Enrolled
Ronald E Frenkel, MDPrincipal InvestigatorEast Florida Eye Institute