Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
NCT ID: NCT02296567
Last Updated: 2015-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
80 participants
INTERVENTIONAL
2014-12-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group 1 Lucentis 4 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Group 2 Avastin 4 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Group 3 Eylea 4 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Group 4 Lucentis 6 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Group 5 Avastin 6 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
Group 6 Eylea 6 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Group 7 Lucentis 8 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
Group 8 Avastin 8 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
Group 9 Eylea 8 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Group 10 Control Group no treatment
Blood samples will be collected from patients who are not receiving anti-VEGF treatment.
Control Group
Control group Subjects will no previous anti-VEGF treatment
Interventions
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Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Control Group
Control group Subjects will no previous anti-VEGF treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. CONTROL GROUP: Age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled.
4. Provide signed informed consent.
Exclusion Criteria
2. Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C \> 12% at screening)
3. Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications.
4. Previous administration of systemic anti-angiogenic medications within 3 months
5. Participation in a simultaneous medical investigation or trial.
6. Treatment within 2 months with anti-VEGF agent in the fellow eye or anticipated need for further treatment during the study.
7. 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.
8. Female patients who have not reached menopause, defined as cessation of menses for a minimum of twelve months with no perimenopausal symptoms.
9. Patients who have significant wound healing during the trial.
10. Patients with a history of vitrectomy in the study eye.
11. patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis.
50 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
East Florida Eye Institute
OTHER
Responsible Party
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Ronald E. Frenkel, MD
Prinicipal Investigator
Principal Investigators
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Ronald E Frenkel, MD
Role: PRINCIPAL_INVESTIGATOR
East Florida Eye Institute
Locations
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East Florida Eye Institute
Stuart, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ML29189
Identifier Type: -
Identifier Source: org_study_id
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