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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ronald E. Frenkel, MD
  • Phone Number: 772.287.9000
  • Email: info@efei.com

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Florida Eye Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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