Back to resultsComparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
Primary Purpose
Age Related Macular Degeneration
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Bevacizumab
Aflibercept
Ranibizumab
Bevacizumab
Aflibercept
Ranibizumab
Bevacizumab
Aflibercept
Control Group
Sponsored by
About this trial
This is an interventional basic science trial for Age Related Macular Degeneration
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- East Florida Eye InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1 Lucentis 4 weeks
Group 2 Avastin 4 weeks
Group 3 Eylea 4 weeks
Group 4 Lucentis 6 weeks
Group 5 Avastin 6 weeks
Group 6 Eylea 6 weeks
Group 7 Lucentis 8 weeks
Group 8 Avastin 8 weeks
Group 9 Eylea 8 weeks
Group 10 Control Group no treatment
Arm Description
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Blood samples will be collected from patients who are not receiving anti-VEGF treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Serum drug levels in nanomoles (nM) units following treatment
Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care treatment.
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
Full Information
NCT ID
NCT02296567
First Posted
November 5, 2014
Last Updated
August 7, 2015
Sponsor
East Florida Eye Institute
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02296567
Brief Title
Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
Official Title
Comparison of Pharmacokinetics of and Effect on Systemic Vascular Endothelial Growth Factor (VEGF) Levels Over Time of Intravitreal Ranibizumab and Bevacizumab and Aflibercept in Age Related Macular Degeneration Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Florida Eye Institute
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Lucentis 4 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Arm Title
Group 2 Avastin 4 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Arm Title
Group 3 Eylea 4 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Arm Title
Group 4 Lucentis 6 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Arm Title
Group 5 Avastin 6 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Arm Title
Group 6 Eylea 6 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Arm Title
Group 7 Lucentis 8 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Arm Title
Group 8 Avastin 8 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Arm Title
Group 9 Eylea 8 weeks
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Arm Title
Group 10 Control Group no treatment
Arm Type
Active Comparator
Arm Description
Blood samples will be collected from patients who are not receiving anti-VEGF treatment.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Control group Subjects will no previous anti-VEGF treatment
Primary Outcome Measure Information:
Title
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Description
Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment.
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Serum drug levels in nanomoles (nM) units following treatment
Description
Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care treatment.
Time Frame
8 weeks
Title
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
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald E. Frenkel, MD
Phone
772.287.9000
Email
info@efei.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald E Frenkel, MD
Organizational Affiliation
East Florida Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald E. Frenkel, MD
Phone
772-287-9000
Email
info@efei.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
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