Trial | NCT02296567  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ranibizumab bevacizumab aflibercept ...

  • Study Participants

    80
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.
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 Started
Dec 31
2014
Primary Completion
Jul 31
2016
Anticipated
Study Completion
Jul 31
2016
Anticipated
Last Update
Aug 11
2015
Estimate

Drug Ranibizumab

Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.

  • Other names: Lucentis

Drug Bevacizumab

Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.

  • Other names: Avastin

Drug Aflibercept

Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.

  • Other names: Eylea

Drug Ranibizumab

Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.

  • Other names: Lucentis

Drug Bevacizumab

Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care

  • Other names: Avastin

Drug Aflibercept

Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care

  • Other names: Eylea

Drug Ranibizumab

Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care

  • Other names: Lucentis

Drug Bevacizumab

Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care

  • Other names: Avastin

Drug Aflibercept

Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care

  • Other names: Eylea

Other Control Group

Control group Subjects will no previous anti-VEGF treatment

Group 1 Lucentis 4 weeks Active Comparator

Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.

Group 2 Avastin 4 weeks Active Comparator

Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.

Group 3 Eylea 4 weeks Active Comparator

Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.

Group 4 Lucentis 6 weeks Active Comparator

Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.

Group 5 Avastin 6 weeks Active Comparator

Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.

Group 6 Eylea 6 weeks Active Comparator

Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.

Group 7 Lucentis 8 weeks Active Comparator

Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.

Group 8 Avastin 8 weeks Active Comparator

Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.

Group 9 Eylea 8 weeks Active Comparator

Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.

Group 10 Control Group no treatment Active Comparator

Blood samples will be collected from patients who are not receiving anti-VEGF treatment.

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.
No Results Posted