Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2014
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
First Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 11, 2015
August 1, 2015
1.6 years
November 5, 2014
August 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment.
up to 8 weeks
Secondary Outcomes (2)
Change in Serum drug levels in nanomoles (nM) units following treatment
8 weeks
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
8 weeks
Study Arms (10)
Group 1 Lucentis 4 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Group 2 Avastin 4 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Group 3 Eylea 4 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Group 4 Lucentis 6 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Group 5 Avastin 6 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Group 6 Eylea 6 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Group 7 Lucentis 8 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Group 8 Avastin 8 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Group 9 Eylea 8 weeks
ACTIVE COMPARATORBlood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Group 10 Control Group no treatment
ACTIVE COMPARATORBlood samples will be collected from patients who are not receiving anti-VEGF treatment.
Interventions
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Control group Subjects will no previous anti-VEGF treatment
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent for participation in this study.
- Adults ≥ 50 years of age with exudative macular degeneration treated with Avastin, Lucentis, or Eylea in previously determined time intervals exclusive to a single anti-VEGF treatment type for not than three months.
- CONTROL GROUP: Age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled.
- Provide signed informed consent.
You may not qualify if:
- Uncontrolled blood pressure (defined as systolic \> 160mm Hg or Diastolic \> 95mm Hg while patient is sitting)
- Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C \> 12% at screening)
- Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications.
- Previous administration of systemic anti-angiogenic medications within 3 months
- Participation in a simultaneous medical investigation or trial.
- Treatment within 2 months with anti-VEGF agent in the fellow eye or anticipated need for further treatment during the study.
- Patients with any cancer diagnosis in remission for less than five years with the exception that patients with skin cancers, basal cell or squamous cell, treated exclusively or topical treatment will be allowed.
- Female patients who have not reached menopause, defined as cessation of menses for a minimum of twelve months with no perimenopausal symptoms.
- Patients who have significant wound healing during the trial.
- Patients with a history of vitrectomy in the study eye.
- patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Florida Eye Institutelead
- Genentech, Inc.collaborator
Study Sites (1)
East Florida Eye Institute
Stuart, Florida, 34994, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald E Frenkel, MD
East Florida Eye Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 20, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
August 11, 2015
Record last verified: 2015-08