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

August 7, 2015 updated by: Ronald E. Frenkel, MD, East Florida Eye Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Stuart, Florida, United States, 34994
        • Recruiting
        • East Florida Eye Institute
        • Contact:
          • Ronald E. Frenkel, MD
          • Phone Number: 772-287-9000
          • Email: info@efei.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ability to provide written informed consent for participation in this study.
  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:

  1. Uncontrolled blood pressure (defined as systolic > 160mm Hg or Diastolic > 95mm Hg while patient is sitting)
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 Lucentis 4 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Drug: Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Other Names:
  • Lucentis
Drug: Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
Other Names:
  • Lucentis
Active Comparator: Group 2 Avastin 4 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Other Names:
  • Avastin
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
Other Names:
  • Avastin
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
Other Names:
  • Avastin
Active Comparator: Group 3 Eylea 4 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Drug: Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Other Names:
  • Eylea
Drug: Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Other Names:
  • Eylea
Active Comparator: Group 4 Lucentis 6 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Drug: Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Other Names:
  • Lucentis
Drug: Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
Other Names:
  • Lucentis
Active Comparator: Group 5 Avastin 6 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Other Names:
  • Avastin
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
Other Names:
  • Avastin
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
Other Names:
  • Avastin
Active Comparator: Group 6 Eylea 6 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Drug: Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Other Names:
  • Eylea
Drug: Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Other Names:
  • Eylea
Active Comparator: Group 7 Lucentis 8 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
Drug: Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
Other Names:
  • Lucentis
Drug: Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
Other Names:
  • Lucentis
Active Comparator: Group 8 Avastin 8 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
Other Names:
  • Avastin
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
Other Names:
  • Avastin
Drug: Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
Other Names:
  • Avastin
Active Comparator: Group 9 Eylea 8 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
Drug: Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
Other Names:
  • Eylea
Drug: Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
Other Names:
  • Eylea
Active Comparator: Group 10 Control Group no treatment
Blood samples will be collected from patients who are not receiving anti-VEGF treatment.
Other: Control Group
Control group Subjects will no previous anti-VEGF treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
Time Frame: up to 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum drug levels in nanomoles (nM) units following treatment
Time Frame: 8 weeks
Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care 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
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Florida Eye Institute

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Ronald E Frenkel, MD, East Florida Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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