Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients

Conditions

• Age Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
• Bevacizumab — DRUG
  Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
• Aflibercept — DRUG
  Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
• Ranibizumab — DRUG
  Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
• Bevacizumab — DRUG
  Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
• Aflibercept — DRUG
  Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
• Ranibizumab — DRUG
  Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
• Bevacizumab — DRUG
  Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
• Aflibercept — DRUG
  Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
• Control Group — OTHER
  Control group Subjects will no previous anti-VEGF treatment

Study Details

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.

Key Dates

Start date

Dec 31, 2014

Status verified

Aug 2015

Primary completion

Jul 31, 2016

Completion

Jul 31, 2016

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Group 1 Lucentis 4 weeks
  Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
• Active Comparator: Group 2 Avastin 4 weeks
  Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
• Active Comparator: Group 3 Eylea 4 weeks
  Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
• Active Comparator: Group 4 Lucentis 6 weeks
  Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
• Active Comparator: Group 5 Avastin 6 weeks
  Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
• Active Comparator: Group 6 Eylea 6 weeks
  Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
• Active Comparator: Group 7 Lucentis 8 weeks
  Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
• Active Comparator: Group 8 Avastin 8 weeks
  Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
• Active Comparator: Group 9 Eylea 8 weeks
  Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
• Active Comparator: Group 10 Control Group no treatment
  Blood samples will be collected from patients who are not receiving anti-VEGF treatment.

Primary Outcome Measure

Change in serum and plasma levels of free Vascular Endothelial Growth Factor [ Time Frame: up to 8 weeks ]

Central Contacts

• Ronald E. Frenkel, MD
  772.287.9000
  [email protected]

Locations (1)

Find similar trials in Stuart, FL

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